The Japanese GMP Regulations 2003

The Japanese GMP Regulations 2003 2 December 2004
Yakuji Nippo, Ltd.
I. Regulations for Buildings and Facilities of Pharmacies etc.
(MHW Ministerial Ordinance No. 2 dated February 1, 1961;

Amended: MHL Ministerial Ordinance No. 16 dated may 20, 2003)
The Regulations for Buildings and Facilities for Pharmacies etc. shall be revised as follows, in accordance
with the provisions of Article 6, Item 1 (including cases where it shall apply mutatis mutandis under
Article 26, Paragraph 2); Article 13, Paragraph 2, Item 1 (including cases where it shall apply mutatis
mutandis under Article 23); Article 28, Paragraph 3, Item 1; and Article 39, Paragraph 2 of the
Pharmaceutical Affairs Law (Law No. 145, 1960)
TABLE OF CONTENTS
Chapter 2 Manufacture of Drugs etc. (Articles 5 - 14-4)
Supplementary Provisions
Chapter 2 Manufacture of Drugs etc.
DRUMBEAT
Concept
(Buildings and Facilities of Manufacturing Sites for Drugs to Which Standards for
Manufacturing Control and Quality Control Shall Not Apply)
Article 5 The buildings and facilities of manufacturing sites for drugs (excluding drugs
specified by the government ordinance pursuant to Article 13, Paragraph 2, Item 2 of the
Law, including cases where it shall apply mutatis mutandis under Article 18, Paragraph 2
of the law; the same in the next article, Article 5-3, and Articles 14 to 14-3 inclusive)
shall meet the following requirements.
(1) To have adequate facilities and equipment for manufacturing drugs at the 9.01
manufacturing site [including a material manufactured in the intermediate 10.01
process which must undergo further processes before a final product
(hereinafter referred to as “intermediate product”); excluding the
provisions of Article 10, Item 2; the same hereinafter].
(2) The area for manufacturing operations (hereinafter referred to as “work

area”) shall meet the following requirements. Proviso: This provision shall
not apply to the requirements D, E and G when the manufacturing process
is carried out prior to the final purification of drugs as active ingredients
(hereinafter referred to as “active pharmaceutical ingredient”) intended for
use in manufacturing drugs, and manufacturing facilities for such process
have an encloses structure.
© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

All rights reserved. P.O. Box 100, West Mystic, CT 06388-0100 USA
Fax: (860) 536-9419 Phone: (860) 572-7255
e-mail: drumbeat@drumkey.com
Page 1 of 46
Yakuji Nippo, Ltd.
DRUMBEAT
Concept
A. To be adequately lighted, illuminated, ventilated and clean. 9.03.01
9.04
B. To be distinctly separated from living quarters and other 9.02

unsanitary areas.
C. To have an adequate area for operations to be performed. 9.01
D. To have facilities for the control of dust, insects, and rodents. 1.09
9.03.01
9.05.02
9.07.02
E. To have floors made of wood, concrete or equivalent materials. 9.07
F. To have facilities or equipment for the disposal of sewage and 1.19.01

waste. 9.10
G. To have disinfection facilities for personnel. 9.06
H. To have facilities for the disposal of poisonous gases if generated 9.03

in manufacturing any particular item of product. 9.10
(3) Among the work areas, work rooms for the weighing operations of raw
materials, and the formulating, filling or sealing operations of drugs
(including work rooms for active pharmaceutical ingredients where the
filling to sealing operations of intermediate products in containers after
the final purification are performed) shall meet the following operations.
A. Work tables in the work room shall be constructed so as not to 9.07

hinder the smooth, proper operations.
B. To be constructed so as not to allow passage for personnel other 11.01

than those working in the room. Proviso: This provision shall not 12.02.09
apply so long as there is no risk of contamination to drugs by
personnel other than those working in the room that can be locked.
C. To have entrances, exits and windows of the room that can be 11.01
locked. 12.02.09
D. To have ceilings made of wood, concrete or materials equivalent 9.07

thereto so as to prevent dust and dirt from falling. 9.07.02

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
E. To have floors made of concrete, tile, mortar or wood with a 9.07
smooth surface free from crevices, or of cleanable materials
equivalent thereto.
F. To have pipes and ducts in the room constructed so as to prevent 9.07.02

accumulation of dust and dirt on their surfaces. Proviso: This
provision shall not apply so long as these pipes and ducts can be
easily cleaned.
(4) To have adequate facilities for the sanitary and safe storage of raw 7.01
materials, packaging and labeling materials, and products.
(5) To have adequate facilities and equipment for the inspection and testing of 9.02.08
raw materials, packaging and labeling materials, and products. Proviso: 9.12
This provision shall not apply so long as the inspection and testing of
drugs undergoing only repackaging are performed on the manufacturer’s
own responsibilities using other testing institutions and this is confirmed
to present no problem and to be unavoidable.
(Buildings and Facilities of Manufacturing Sites for Drugs Other Than Active
Pharmaceutical Ingredients to Which the Standards for Manufacturing Control
and Quality Control of Drugs Shall Not Apply)
Article 5-2 The buildings and facilities of manufacturing sites for drugs other than active
pharmaceutical ingredients (limited to drugs specified by the government ordinance
pursuant to Article 13, Paragraph 2, Item 2 of the Law) shall meet the following
requirements.
manufacturing site. 10.01
(2) To be appropriately positioned so as to facilitate the smooth and proper 9.01

operations, and cleaning. 10.01
(3) Work areas shall meet the following requirements.
A. To be adequately lighted, illuminated, ventilated and cleaned. 9.03.01

9.04

unsanitary areas.
C. To have an adequate area for performing the operations. 9.01

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
D. To have facilities for the control of dust, insects and rodents. 1.09
9.03.01
9.05.02
E. To have facilities or equipment for the disposal of sewage and 1.19.01

waste. 9.10
F. To have disinfection facilities for personnel. 9.06
G. To have facilities for the disposal of poisonous gases, if generated 9.03

H. Among the work areas, the work room shall be provided with 9.03.01
structures and facilities for prevention of contamination by dust or
microorganisms according to the type, dosage form and
manufacturing process of intended drugs. Proviso: This provision
shall not apply so long as the same effects are obtained from the
functions of the manufacturing facilities.
I. When a drug which is easily dispersed and causes anaphylaxis in 5.28

minute amounts or a drug which is suspected to have serious 5.28.01
effects on other drugs by cross-contamination is manufactured 6.18
simultaneously with other drugs, the work room and air-treatment
system shall be separated from those used for other drugs.
J. To have washing and toilet facilities and dressing rooms. 9.06
K. Among the work areas, the work room for the weighing operations
of raw materials, and the formulating, filling or sealing operations
of drugs shall meet the following requirements.
(i) Work tables in the work room shall be constructed so as 9.07

not to hinder the smooth and proper operations.
(ii) To be constructed so as not to allow the passage of 11.01

personnel other than those working in the room. Proviso: 12.02.09
This provision shall not apply so long as there is no risk of
contamination to drugs by personnel other than those
working in the room.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
(iii) To have no entrances or exits opening to the exterior, 9.01
except for emergency exits, shall be provided. 11.01
12.02.09
(iv) To have entrances, exits and windows of the room that can 11.01
be locked. 12.02.09
(v) Water discharging facilities in the room shall be 9.07.01

constructed so as to prevent contamination of the room. 9.08
9.08.01
(4) To have adequate facilities for the sanitary and safe storage of raw 7.01
materials, packaging and labeling materials and drug products that are
separated.
(5) To have facilities for supply of water of the amount and quality required 5.19
for manufacture (including water for cleaning facilities and equipment as 9.08
well as containers; the same in the next article) according to the type of 9.08.01
drugs.
(6) To have facilities and equipment for the inspection and testing of raw 9.02.08
materials, packaging and labeling materials, and products. Proviso: This 9.12
provision shall not apply to the facilities and equipment for the following
inspection and testing so long as the inspection and testing are performed
on the manufacturer’s own responsibilities using the following testing
facilities or institutions and this is confirmed to present no problem and to
be unavoidable.
A. Inspection and testing of drugs undergoing only repackaging:

Other testing institutions.
B. Inspection and testing of raw materials, and packaging and

labeling materials: Other testing facilities of the manufacturer or
testing institutions specified under Article 11, Paragraph 1 of the
Enforcement Regulations.
C. High level physicochemical or animal tests of drugs: Other testing

facilities of the manufacturer or testing institutions specified under
Article 11, Paragraph 1 of the Enforcement Regulations.
D. Inspection and testing of products, excluding the tests in C: Other

testing facilities of the manufacturer.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
(Buildings and Facilities of Manufacturing Sites for Active Pharmaceutical
Ingredients to Which the Standards for Manufacturing Control and Quality
Control Shall Not Apply)
Article 5-3 The buildings and facilities of manufacturing sites for active pharmaceutical
ingredients (limited to drugs specified by the government ordinance pursuant to Article
13, Paragraph 2, Item 2 of the Law) shall meet the following requirements.
manufacturing site.
(2) To be properly positioned so as to facilitate the smooth and proper 9.01

operations, cleaning and maintenance.
(3) To have washing and toilet facilities and dressing rooms. 9.06
(4) Work areas shall meet the following requirements: Proviso: This provision
shall not apply to the requirements D and F when the manufacturing
process is carried out prior to the final purification, and manufacturing
facilities for such process have an enclosed structure.
A. To be adequately lighted, illuminated, ventilated and cleaned. 9.03.01

9.04

unsanitary areas.
C. To have an adequate area for performing operations. 9.01
D. To have facilities for the control of dust, insects and rodents. 1.09
9.03.01
9.05.02
E. To have facilities or equipment for the disposal of sewage and 1.19.01

waste. 9.10
F. To have disinfection facilities for personnel. 9.06
G. To have facilities for the disposal of poisonous gases if generated 9.03


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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
H. Manufacturing facilities for active pharmaceutical ingredients 5.28
where substances causing anaphylaxis in minute or those 5.28.01
suspected to have serious effects on other drugs by cross- 6.18
contamination are produced in the intermediate process. When a
drug which is easily dispersed and causes anaphylaxis in minute
amounts shall have the functions to prevent other drugs from
contamination of such substances.
(5) The work area for performing manufacturing processes subsequent to the
final purification shall meet the following requirements in addition to
those in A to H of the preceding item.
A. Among the work areas, work rooms shall be provided with 9.03.01
structures and facilities for prevention of contamination by dust or
microorganisms according to the type, dosage form, physical
properties and manufacturing process of intended drugs. Proviso:
This provision shall not apply so long as the same effects are
obtained from the functions of the manufacturing facilities, etc.
B. When a drug which is easily dispersed and causes anaphylaxis in 5.28

minute amounts or a drug which is suspected to have serious 5.28.01
effects on other drugs by cross-contamination is manufactured 6.18
simultaneously with other drugs, the work room and air-treatment
system shall be separated from those used for other drugs.
C. Among the work areas, the work room for the filling to sealing
operations of intermediate products in containers which have
undergone the final purification shall meet the following
requirements.
(i) Work tables in the work room shall be constructed so as 9.07

not to hinder the smooth and proper operations.
(ii) To be constructed so as not to allow the passage of 11.01

personnel other than those working in the room. Proviso: 12.02.09
This provision shall not apply so long as there is no risk of
contamination to drugs by personnel other than those
working in the room.
(iii) To have no entrances or exits opening directly to the 11.01

exterior, except for emergency exits. 12.02.09

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
(iv) To have entrances, exits and windows of the room that can 11.01
be locked. 12.02.09
(v) The water discharging facilities in the room shall be 9.07.01

constructed so as to prevent contamination of the room. 9.08.01
(6) To have facilities for the sanitary and safe storage of raw materials, 7.01
packaging and labeling materials and products which are separated.
(7) To have facilities for supply of water of the quality and quantity needed 5.19
for manufacturing according to the type of drugs. 9.08
9.08.01
(8) To have facilities and equipment for the inspection and testing of raw 9.02.08
materials, packaging and labeling materials and products. Proviso: This 9.12
provision shall not apply to the facilities and equipment for the inspection
and testing of the following matters so long as the inspection and testing
are performed on the manufacturer’s own responsibilities using the
following testing facilities or institutions A to D and this is confirmed to
present no problem and to be unavoidable.
A. Inspection and testing of drugs undergoing only repackaging:

Other testing institutions.
B. Inspection and testing of raw materials, and packaging and

labeling materials: Other testing facilities of the manufacturer or
testing institutions specified under Item 6-B of the preceding
article.
C. High level physicochemical or animal tests of drugs: Other testing

facilities of the manufacturer or testing institutions specified in
Item 6-C of the preceding article.
D. Inspection and testing of products (excluding the tests in C) Other

testing facilities of the manufacturer.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
(Buildings and Facilities of Manufacturing Sites for Sterile Products)
Article 6 The buildings and facilities of the manufacturing sites for sterile products
[(injectable drug products, excluding blood products not constituting a lot pursuant to
Article 1, Paragraph 2 of the Regulations for Manufacturing Control and Quality Control
of Drugs and Quasi-drugs (MHW Ministerial Ordinance No. 16, 1999), eye drops, eye
ointment or biological products (excluding blood products not constituting a lot, and
drugs intended for exclusive use in the diagnosis of diseases and those directly used in
the human body; the same in this article and Article 7), and water for injections; the same
hereinafter) shall meet the following requirements in addition to those specified under
Article 5-2.
A. Among the work areas, the work room or working control area 1.12
(the area consisting of work rooms, passage, etc. that are 9.03
controlled so as to maintain a uniform quality of cleanliness; the 9.03.01
same hereinafter) shall be provided with adequate structures and
facilities for maintaining appropriate temperature, humidity and
cleanliness according to the type, dosage form and manufacturing
process of intended sterile products.
B. The work room for the weighing operations of raw materials and 9.03.02
for the washing operations of containers shall have an enclosed
structure for protection against dust.
C. The work room for the drying and sterilization operations of 1.12.03
containers after washing shall be used exclusively for that purpose. 9.02.10
Proviso: This provision shall not apply so long as there is no risk
of contamination of containers after washing.
D. The work room or work control area for the formulating, filling or
sealing operations of drugs shall meet the following requirements.
(i) To be separated from the work area for drugs other than 9.02
sterile products and sterile active pharmaceutical
ingredients (refer to active pharmaceutical ingredients that
are sterile, excluding intermediate product; the same
hereinafter). Proviso: This provision shall not apply so long
as there is no risk of contamination of sterile products.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
(ii) The ceilings, walls and floors of the room shall have 9.07
surfaces made of materials able to withstand spray washing
with disinfectant solutions.
(iii) To have facilities and equipment that allow sterilization 9.01

and disinfection. 10.01
(iv) The work room for the formulating operations and for the 1.12
filling or sealing operations shall be used exclusively for 9.02
their respective purposes. Proviso: When the formulating
and filling operations, or the formulating, filling or sealing
operations are performed continuously in a closed system,
these operations may be performed in the same room.
When the filling and sealing operations of sterile products
other than injections are performed in a closed system, both
operations may be performed in the same room as the
formulating operations. Separate rooms for the preparing
operations and for the filling or sealing operations of
radiopharmaceuticals shall not be used.
(v) When injectable drug products and other sterile products 1.12
are manufactured in the same room, manufacturing 9.02
facilities for injectable drug products shall be in a closed
system and used exclusively for that purpose.
E. To have dressing rooms for exclusive use by personnel engaging 9.06

in operations in C. Proviso: This provision shall not apply with the
following facilities.
(2) Work areas shall be provided with the following facilities.
A. Facilities for drying, sterilization and storage of containers after 1.12.03

washing. 9.02.10
B. Facilities for formulating drugs. Among these facilities, an open 9.03

filtration system shall be provided with a cover, and a closed
filtration system with purification equipment for air replenished.
C. Facilities for filling drugs. 9.02.07
D. Facilities for sealing containers. 9.02.07

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
E. In the case of liquid injectable drug products, purification 5.30.01
equipment for air replenished in a tank for storing stock solutions.
F. Purification equipment for air replenished in containers of 5.30.01

injectable drug products.
(3) To have sterilization equipment for manufacturing according to the type 10.01
of intended sterile products.
(4) To have indoor facilities for manufacturing distilled water, etc. (including 5.19
cleaning water for facilities and equipment, and containers; the same
hereinafter) of the quality or quantity needed for manufacturing according
to the type of sterile products. Proviso: It is not necessary to install these
facilities indoors when they have an enclosed system.
(5) Facilities such as pipes to supply distilled water, etc. for manufacturing 5.19.01
shall be constructed so as to prevent contamination of distilled water, etc. 5.19.02
by foreign matter or microorganisms.
(6) The following facilities and equipment for the inspection and testing of 9.02.08
the following matters shall be provided. In such cases, the proviso in Item 9.12
6, Article 5-2 shall apply mutatis mutandis.
A. Facilities and equipment for the inspection and testing of in the

hermetic condition where necessary.
B. Facilities and equipment for the inspection and testing of a foreign

matter.
C. Facilities and equipment for the physicochemical inspection and

testing of raw materials, packaging and labeling materials, and
products.
D. Facilities and equipment for the sterility tests.
E. Facilities and equipment for the pyrogen tests where necessary.
F. Facilities and equipment for the biological tests where necessary.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
(Buildings and Facilities of Manufacturing Sites for Sterile Active Pharmaceutical
Ingredients)
Article 6-2 The buildings and facilities of manufacturing sites for sterile active
pharmaceutical ingredients shall meet the following requirements in addition to those
specified under Article 5-3.
A. Among the work areas, the work room or working control area 1.12
shall be provided with adequate structures and facilities for 9.03
maintaining appropriate temperature, humidity and cleanliness 9.03.01
according to the type, physical properties and manufacturing
process of intended sterile active pharmaceutical ingredients.
B. The work room for washing containers (limited to those used in 1.12.03
the operations subsequent to the preparing operations intended for 9.02.10
sterilization; the same in this article) shall have an enclosed
structure for protection against dust.
C. The work room for the drying or sterilization operations of 9.02

containers after washing shall be used exclusively for that purpose.
Proviso: This provision shall not apply so long as there is no risk
of contamination of containers after washing.
D. The work room for operations (excluding labeling and packaging

operations) subsequent to the preparing operations intended for
sterilization shall meet the following requirements. Proviso: This
provision shall not apply so long as microbial proliferation can be
inhibited in the formulating conditions.
(i) To be separated from the work area for drugs other than 9.02
sterile products and sterile active pharmaceutical
ingredients. Proviso: This provision shall not apply so long
as there is no risk of contamination of sterile active
pharmaceutical ingredients.
(ii) The ceilings, walls and floors of the room shall have their 9.07
surfaces made of materials able to withstand spray washing
with disinfectant solutions.
(iii) To have facilities and equipment that allow sterilization 9.01

and disinfection. 10.01

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
E. To have dressing rooms for exclusive use by personnel engaged in 9.06
operations in specified in D.
(2) The work area shall be provided with the following facilities and
equipment.
A. Facilities for drying, sterilization and storage of containers after 9.02.10

washing.
B. Facilities for preparation intended for sterilization. 9.02
C. Facilities or equipment for filling sterile active pharmaceutical 1.12

ingredients.
D. Facilities or equipment for sealing containers. 1.12

9.02.07
(3) To have sterilization facilities for manufacturing according to the type of 9.02
sterile active pharmaceutical ingredients. 9.15
(4) To have indoor facilities for manufacturing distilled water, etc. of the 5.19
quality and quantity needed for manufacturing according to the type of
sterile active pharmaceutical ingredients. Proviso: It is not necessary to
install these facilities indoors when they have an enclosed structure.
(5) Facilities such as pipes to supply distilled water, etc. required for 5.19.01
manufacturing shall be constructed so as to prevent contamination of 5.19.02
distilled water, etc. by foreign matter or microorganisms.
(6) To have the following facilities and equipment for inspection and testing. 9.02.08
In such cases, the proviso of Article 5-3, Item 8 shall apply mutatis 9.12
mutandis.
A. Facilities and equipment for inspection and testing in the hermetic

condition, where necessary
B. Facilities and equipment for the inspection and testing of a foreign

matter
C. Facilities and equipment for the physicochemical inspection and

testing of raw materials, packaging and labeling materials, and
products

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
D. Facilities and equipment for sterility tests
E. Facilities and equipment for pyrogen tests, where necessary
F. Facilities and equipment for biological tests, where necessary.
(Buildings and Facilities of Manufacturing Sites for Biological Preparations)

Article 7 The buildings and facilities of manufacturing sites for biological preparations
shall meet the following requirements in addition to those specified under Articles 5-2
and 6.
(1) The work area for biological preparations shall be provided with the
following facilities. Proviso: The facilities confirmed it unnecessary to
manufacture the preparations according to the type, manufacturing
method, etc. of biological preparations shall be excluded.
A. Storage facilities for microorganisms. 9.02.15
B. Facilities for keeping animals for use in manufacturing or in 9.11

testing after inoculation of microorganisms.
C. Facilities for treating animals for use in manufacturing or in testing 9.11
D. Facilities for inoculating microorganisms into culture media etc. 9.02.15
E. Facilities for cultivating microorganisms 9.02.15
F. Facilities for collecting, inactivating and sterilizing cultured 9.02.15

microorganisms
G. Facilities for preparing diluents for stock solutions. 9.02.15
H. Facilities for diluting and subdividing stock solutions and for 9.02.15
sealing containers.
I. Facilities for disinfecting devices and equipment that have been 1.04
used in manufacturing or in testing

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DRUMBEAT
Concept
(2) The facilities specified under the preceding item shall be provided with 5.28.01
rooms which are distinctly separated from other rooms, and rooms 6.18
provided with the facilities indicated in A, B, D or I of the preceding item,
which are used to treat smallpox viruses, acute poliomyelitis viruses,
spore-forming pathogens or Mycobacterium tuberculosis, shall be used
exclusively for treating each type of biological preparation and strictly
isolated from other rooms.
(3) The ceilings, walls and floors of the room provided with the facilities 9.07
indicated Item 1, B to D, and F to H shall have their surfaces constructed
so as to allow washing and disinfection.
(4) The room provided with the facilities indicated in Item 1, D and F to H
inclusive and the room provided with the facilities for the sterility tests,
among the facilities for testing raw materials, labeling and packaging
materials, shall meet the following requirements.
A. Work rooms shall be aseptic. Proviso: This provision shall not 1.12
apply so long as a room provided with an aseptic box where 1.12.01
aseptic operations can be carried out, according to the type,
manufacturing method, etc. of biological preparation.
B. The aseptic room in A shall have an adjacent anteroom which 1.12

allows exclusive passage of personnel to and from the work room
and whose entrances and exits are not opening directly to the
exterior.
(5) The work area shall be provided with the following facilities in addition to
those specified in Item 1.
A. Facilities for breeding and managing animals for use in 9.11

manufacturing or in testing.
B. Facilities for preparing culture media and diluents for the media.
C. Facilities for washing and sterilization of equipment/instruments, 9.02.23

containers, etc. which are used in manufacturing or in testing.
D. Facilities for incinerating animal carcasses and other biological 1.19.01

waste as well as for purifying sewage. 9.10
E. Dressing rooms and bathrooms for exclusive use by personnel. 9.06

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DRUMBEAT
Concept
(6) Storage facilities shall be provided with thermostats, self-recording 7.01
thermometers and other required meters. 10.04
(Buildings and Facilities of Manufacturing Sites for Blood Products Not

Constituting a Lot)
(Test deleted, not applicable)
(Buildings and Facilities of Manufacturing Sites for Biological Preparations etc.)

Article 8-2 Specified biological products specified under Article 2, Paragraph 6 of the
Law (hereinafter referred to as “specified biological product”), biological preparations
specified under Article 15-4, Paragraph 2, Item 2-A of the Enforcement Ordinance of the
Law, drugs designated by the Minister pursuant to the provisions of Article 43,
Paragraph 1 of the Law, drugs manufactured by application of gene recombination
technology, drugs provided as source materials drugs manufactured by application of
gene recombination technology, drugs manufactured by application of incubation
technology of human or animal cells, drugs provided as source materials drugs
manufactured by application of incubation technology of human or animal cells, or
cellular/tissue based drugs (hereinafter referred to as “biological preparation etc.”), for
which the buildings and facilities of manufacturing sites shall meet the following
requirements in addition to those specified under Article 5-2 to Article 8 inclusive.
A. Clean areas (refer to the clean areas specified under Article 1,

Paragraph 5 of the Regulations for Manufacturing Control and
Quality Control of Drugs and Quasi-drugs; the same in this item)
and aseptic areas (refer to the aseptic areas specified under Article
1, Paragraph 6 of the Regulations for Manufacturing Control and
Quality Control of Drugs and Quasi-drugs; the same in this item)
shall meet the following requirements.
(i) The ceilings, walls and floors with a smooth surface and 9.07
free from crevices shall be constructed so as to prevent dust 9.07.02
and dirt from falling.
(ii) Water discharging facilities shall have adequate structures 5.19

for prevention of contamination with poisonous sewage. 9.08
B. The outlet for discharge shall not be provided with the clean area.
Proviso: This provision shall not apply so long as the requirements
in the following (i) to (iii) are met and this is confirmed to present
no problem.

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DRUMBEAT
Concept
(i) The outlet for discharge shall be provided with drainage 5.19
trap that is easy to clean, and equipment for preventing 9.07.01
water from flowing backward. 9.08.02
(ii) The trap shall have structures that can be disinfected. 9.07.01
9.08.02
(iii) The grooves of the floor shall be shallow, easy to clean and 9.07
connect through the outlet for discharge to the outside of 9.07.01
the manufacturing area (refer to a site for performing the
operations to incubate, extract and purify, weigh raw
materials, wash and dry containers, formulate and fill
drugs, and to seal and package containers, as well as a site
for dressing; the same in this item).
C. Aseptic areas shall meet the following requirements:
(i) The outlet for discharge shall not be provided with the 1.12
aseptic area.
(ii) The sink shall not be provided with the aseptic area. 1.12
D. The area for performing tests using animals and microorganisms, 9.02.08
and for treating animal tissues and microorganisms that are not 9.02.15
used in manufacturing biological preparations etc. shall be
distinctly separated from other areas for manufacturing biological
preparations etc., and air handling systems shall be exclusively
provided.
E. The area for performing aseptic operations shall be provided with 9.03.01
structures and facilities for controlling positive pressure.
F. The area for treating pathogenic microorganisms shall be provided 9.03.01

with structures and facilities for the proper control of negative
pressure.
G. The area for treating infectious microorganisms shall be provided 1.19.01

with facilities for the washing, sterilization and disinfection of the 9.01
equipment that have been used in the area, as well as that for the 9.10
disposal of discharged liquids.

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DRUMBEAT
Concept
H. The area for manufacturing drugs with human blood or plasma as 9.02
raw materials shall be distinctly separated from other areas and
shall be provided with facilities and equipment exclusively for
manufacturing such drugs. Proviso: This provision shall not apply
to the area for performing the processes subsequent to the virus
inactivation or elimination.
I. The equipment/instruments used in the work room for treating 5.28.01

smallpox viruses, acute poliomyelitis viruses, spore-forming
pathogens or Mycobacterium tuberculosis for use in manufacturing
shall be labeled according to the type of products and exclusively
used for that purpose.
(2) Air handling systems shall meet the following requirements.
A. To have adequate structures for preventing raw materials or 5.28

products from contaminating with microorganisms, etc. 9.03.01
B. When pathogenic microorganisms, etc. are used, adequate 5.28.01

structures for preventing such microorganisms from spreading into
the air shall be provided.
C. To have the structures constructed so as to discharge the air 5.28.01

emitted from the area for treating pathogenic microorganisms, etc. 9.03.01
after removal of such microorganisms through the high-efficiency
particulate air filter (HEPA).
D. To have the structures constructed so as not to cause recirculation 5.28

of the air in the work room for the operations that are suspected to 9.03.01
cause leakage of pathogenic microorganisms, etc. Proviso: This
provision shall not apply so long as such microorganisms etc. are
completely removed from the air as specified in C of this
paragraph and it is confirmed that such recirculation is
unavoidable.
E. Air handling systems shall be provided exclusively with respective 9.03.01

work rooms where necessary.
(3) Pipes, valves and bent filters shall be constructed so as to facilitate 10.01
cleaning and sterilization according to the purpose of use.

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DRUMBEAT
Concept
(4) Facilities for keeping animals for use in manufacturing or in testing 9.11
(including donor animals; hereinafter, refer to as “use animals” in this
item) shall meet the following requirements.
A. To have quarantine areas for use animals are separated from other
areas.
B. To have storage facilities for feed that cannot be invaded by

insects.
C. To have breeding rooms for animals for use in manufacturing that

are separated from those for animals for use in testing.
D. To have air handling systems provided with breeding rooms for

use animals that are separated from those for other areas. Proviso:
This provision shall not apply to animals considered it proper to be
bred outside.
E. To have rooms for inoculating antigens into animals, where

necessary. In such cases, rooms for inoculation shall be separated
from those for autopsy.
(Buildings and Facilities of Manufacturing Sites for Cellular/Tissue Based Drugs)

(Text deleted, not applicable)
(Buildings and Facilities of Manufacturing Sites for Radiopharmaceuticals)

(Buildings and Facilities of Manufacturing Sites for Absorbent Gauze and

Absorbent Cotton)

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DRUMBEAT
Concept
(Buildings and Facilities of Manufacturing Sites for Quasi-drugs to Which
Standards for Manufacturing Control and Quality Control Shall Not Apply)
Article 12 To the buildings and facilities of manufacturing sites for quasi-drugs 9.01
(excluding quasi-drugs stipulated by the government ordinance pursuant to Article 13, 10.01
Paragraph 2, Item 2 of the Law), the provisions of Article 5 (excluding Item 5) shall
apply mutatis mutandis, and adequate facilities and equipment for the inspection and
testing of raw materials, labeling and packaging materials, and products shall be
provided. Proviso: This provision shall not apply to the facilities and equipment for the
inspection and testing of the following matters so long as the inspection and testing are
performed on the manufacturer’s own responsibilities using the following testing
facilities or institutions and this is confirmed to present no problem to the proper testing.
(1) Inspection and testing of quasi-drugs undergoing only repackaging: other

testing facilities
(2) High level physicochemical or animal tests: other testing facilities for the
manufacturer or testing institutions specified under Article 11, Paragraph
1 of the Enforcement Regulations.
(Buildings and Facilities of Manufacturing Sties for Quasi-drugs to Which

Standards for Manufacturing Control and Quality Control Shall Apply)
Article 12-2 The provisions of Article 5-2 (excluding Item 3-I) shall apply mutatis
mutandis to the buildings and facilities of manufacturing sites for quasi-drugs stipulated
by the government ordinance pursuant to Article 13, Paragraph 2, Item 2 of the Law.
(Buildings and Facilities of Manufacturing Sites for Cosmetics)

Article 13 The buildings and facilities of manufacturing sites for cosmetics shall meet
the following requirements.
(1) To be provided with adequate facilities and equipment for manufacturing 9.01
of products at the manufacturing site. 10.01
(2) To have work areas which shall meet the following requirements.
A. To be adequately lighted, ventilated and clean. 9.03.01

9.04

unsanitary areas.
C. To have adequate areas for performing the proper operations. 9.01

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DRUMBEAT
Concept
D. To be provided with facilities for the control of dust, insects and 1.09
rodents. 9.03.01
9.05.02
E. To have floors made of wood, concrete or materials equivalent 9.07

thereto.
F. To have adequate facilities or equipment for the disposal of 1.19.01

discharged water and waste materials. 9.10
(3) To be provided with adequate facilities for the sanitary and safe storage of 7.01
raw materials, labeling and packaging materials, and products.
(4) To be provided with adequate facilities and equipment for the inspection 9.02.08
and testing of raw materials, labeling and packaging materials, and 9.12
products. Proviso: This provision shall not apply to the facilities and
equipment for the inspection and testing of the following matters so long
as the inspection and testing are performed on the manufacturer’s own
responsibilities using the following testing facilities or institutions and this
is confirmed to present no problem to the proper testing.
A. Inspection and testing of cosmetics undergoing only repackaging:

other testing facilities
B. High level physicochemical or animal tests: other testing facilities

of the manufacturer or testing institutions specified under Article
11, Paragraph 1 of the Enforcement Regulations.

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DRUMBEAT
Concept
(Date of Enforcement)
1. This ordinance shall come into effect on the date of enforcement (February 1,
1961).
Attached Table
Sign Size Location of Sign
On radioactivity signs as specified Radioactivity signs shall have a The sign shall be posted at the
under Article 17, Paragraph 1 of radius of at least 10 cm. entrance or exit of the storage
the Japan Industrial Standards in room or its vicinities.
accordance with the Industrial
Standardization Law (Law No.
185, 1949), the upper part shall
indicate “Storage Room” and the
lower part “Unauthorized Entry
Prohibited.”

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Yakuji Nippo, Ltd.
II. Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs
(MHW Ministerial Ordinance No. 16 dated March 12, 1999;

Amended: MHLW Ministerial Ordinance No. 95 dated May 20, 2003)
In accordance with the provisions of Article 13, Paragraph 2, Item 2 (including cases where it shall apply
mutatis mutandis under Article 18, Paragraph 2) of the Pharmaceutical Affairs Law (Law No. 145, 1960),
the whole text of the Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-
drugs shall be revised as stated below.
TABLE OF CONTENTS
Chapter 1 General Provisions (Article 1)
Chapter 2 Manufacturing Control and Quality Control of Drugs
Section 1 General Rules (Articles 2 - 4)

Section 2 Manufacturing Control (Articles 5 and 6)
Section 3 Quality Control (Articles 7 and 8)
Section 4 Other Duties Related to the Manufacturing Sites (Articles 9 - 14)
Section 5 Manufacture at Two or More Manufacturing Sites (Articles 15 and 16
Section 6 Miscellaneous Provisions (Article 16-2)
Chapter 3 Manufacturing Control and Quality Control of Quasi-drugs (Article 17)
Chapter 1 General Provisions
DRUMBEAT
Concept
(Definitions)
Article 1 The term “labeling and packaging materials” used in this ordinance means
containers, wrappers and package inserts of a product, and labels pasted on the containers
and wrappers.
2. The term “lot” used in this ordinance means a batch of products manufactured so
as to have a uniform quality during a series of manufacturing processes within a
unit of manufacturing period [including a material manufactured during the
process which must undergo subsequent processes before a final product is
obtained (hereinafter referred to as “intermediate product”; the same under
Article 3, Paragraph 1, Item 2; Article 6, Paragraph 1, Item 2-D and Paragraph 2,
Item 1-A, G and J; and Article 8, Paragraph 1, Item 1-A and B) and raw
materials.

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DRUMBEAT
Concept
3. The term “control unit’ used in this ordinance means a batch of labeling and
packaging materials which are confirmed to have a uniformity quality.
4. The “validation” used in this ordinance means to validate and document that
anticipated results yield from the buildings and facilities at manufacturing sites as
well as operating procedures, processes and other methods of manufacturing
control and quality control (hereinafter referred to as “the operating procedures
etc”).
5. The term “clean area” used in this ordinance means, among the areas for
performing manufacturing operations (hereinafter referred to as “work area”), a
place for performing the weighing operations of raw materials and the preparing
operations of drugs, and a place where containers after washing are exposed to
the air in the work area.
6. The term “aseptic area” used in this ordinance means, among the work area, a
place where drugs being sterile and containers after sterilization are exposed to
the air in the work area, a place for performing the filling operations of drugs and
the sealing operations of containers, as well as a place for performing aseptic
operations such as sterility tests etc.
7. The term “cellular/tissue based drug” used in this ordinance means drugs
composed of human or animal cells or tissues (excluding human blood and drugs
composed of ingredients manufactured with human blood).
8. The term “donor” used this ordinance means an individual providing her (his)
cells or tissues as raw materials of cellular/tissue based drugs (excluding cells or
tissues derived from the human body with brain death as specified under Article
6, Paragraph 2 of the Law on Organ Transplantation (Law No. 104, 1997).
9. The term “donor animal” used in this ordinance means an animal providing its
cells or tissues as the source materials of cellular/tissue based drugs.

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Chapter 2 Manufacturing Control and Quality Control of Drugs
DRUMBEAT
Concept
Section 1 General Rules
(Manufacturing Control Manager and Quality Control Manager)
Article 2 A manufacturer of drugs (hereinafter referred to as “manufacturer”) shall 13.01
designate, at each manufacturing site, a person responsible for the manufacturing control 13.02
unit as the manufacturing control manager and a person responsible for the quality 13.11
control unit as the quality control manager, who perform their duties under the
supervision of a product security pharmacist (hereinafter referred to as “product security
pharmacist”).
2. The quality control unit shall be independent of the manufacturing control unit.
3. The manufacturing control manager shall not hold a position as the quality
control manager concurrently.
(Product Security Pharmacist)

Article 3 The product security pharmacist shall perform the following duties. 13.11
(1) To supervise the manufacturing control manager and the quality control
manager.
(2) To decide, through appropriate evaluation of results of the manufacturing 6.07.03

control and quality control, whether or not to release the product out of the
manufacturing site.
(3) To ensure that the validation, self-inspection and training, as well as the
confirmation specified under Article 15, Paragraph 5, Item 1, are properly
carried out, by documents reported as specified under Article 10,
Paragraph 1, Item 2; Article 13, Paragraph 1, Item 2; Article 14,
Paragraph 1, Item 2; and Article 15, Paragraph 5, Item 2.
(4) The duties specified under Article 11 and 12.
2. The manufacturer shall make efforts for the effective performance of the duties
assigned to the product security pharmacist.
(Product Master Formula)

Article 4 The manufacturer shall prepare, at each manufacturing site involved in the 5.02
manufacture of the drug, a product master formula, for each product, describing the
following matters.

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DRUMBEAT
Concept
(1) Terms concerning manufacturing approval;
(2) Manufacturing procedures;
(3) In cases where drugs intended for manufacture are biological products
specified under Article 2, Paragraph 5 of the Law (Law No. 145, 1960)
(hereinafter referred to as “biological product”), biological preparations
indicated in Item 2-A, Paragraph 2, Article 15-4 of the Enforcement
Ordinance of the Law (Government Ordinance No. 11, 1961), drugs
designated by the Minister pursuant to the provisions of Article 43,
Paragraph 1 of the Law, drugs manufactured by application of gene
recombination technology, drugs provided as the source materials drugs
manufactured by application of gene recombination technology, drugs
manufactured by application of incubation technology of human or animal
cells, or drugs provided as the source materials drugs manufactured by
application of incubation technology of human or animal cells, or
cellular/tissue based drugs (hereinafter referred to as “biological
preparations etc.”), describe the following matters.
A. Name, essence, description, ingredients and their contents, and

other specifications of a drug obtained from humans, animals,
plants or microorganisms provided as the source materials.
B. Specifications of animals for use in manufacturing or in inspection

and testing (including methods of breeding and keeping animals)
(including donor animals; hereinafter referred to as “use animal”).
(4) Other necessary matters.
Section 2 Manufacturing Control

(Manufacturing Control Standard Code and Manufacturing Hygiene Control
Standard Code)
Article 5 The manufacturer shall prepare, at each manufacturing site, a manufacturing 1.02
control standard code describing storage of raw materials etc., control of the 7.01
manufacturing process and other necessary matters, as well as at each work area, a 12.02
manufacturing hygiene control standard code describing the sanitation and hygiene of the
buildings and facilities (excluding those provided for inspection and testing; the same
hereinafter), and personnel, and other necessary matters.

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DRUMBEAT
Concept
(Duties of Manufacturing Control Manager)
Article 6 The manufacturer shall have the manufacturing control manager perform 13.05
appropriately the following duties related to the manufacturing control of drugs in
accordance with the product master formula, the manufacturing control standard code or
the manufacturing hygiene control standard code.
(1) To prepare a manufacturing order describing instructions, precautions and 5.01

other necessary matters during the manufacturing process.
(2) To perform by herself/himself, or according to the type of duties, to have a

person, designated beforehand, perform the following duties.
A. To manufacture drugs in accordance with the manufacturing order.
B. To prepare records of manufacturing drugs by lot (by 5.03

manufacturing number in case of drugs not constituting a lot; the
same hereinafter).
C. To confirm whether or not the labeling and packaging of product 5.03.02

are properly performed for each lot, and to prepare records of the
confirmation results.
D. To store appropriately raw materials and products by lot, and 3.01

labeling and packaging materials by control unit, manage 3.02
receipt/distribution of such materials and products, and to prepare 3.10
the records thereof. 4.01
4.02
E. To confirm cleanliness of the buildings and facilities, and to 1.01

prepare records of the confirmation results.
F. To perform the sanitation and hygiene of personnel, and to prepare 12.02.01

the records thereof.
G. To perform the periodical inspection for maintenance of the 2.02

buildings and facilities (including calibration of meters), and to 2.02.04
prepare the records thereof
H. Other necessary duties.

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DRUMBEAT
Concept
(3) To confirm from records of storage, receipt/distribution, as well as those 8.01.01
of the manufacturing hygiene control that the manufacturing control is
properly performed, and report the results of the confirmation in writing to
the product security pharmacist.
(4) To retain records of manufacture, storage, receipt/distribution, as well as

those of the manufacturing hygiene control, for the following periods from
the date of preparation.
A. Three years for drugs other than biological products or

cellular/tissue based drugs (hereinafter referred to as “biological
products etc.”) [when a drug related to the records is obliged to
bear an expiry date or the date of expiry (hereinafter referred to as
“expiry date”), a period of the expiry date plus one year].
B. A period of the expiry date plus 30 years for specified biological

products prescribed under Article 2, Paragraph 6 of the Law
(hereinafter referred to as “specified biological product”) or for
biological products manufactured with human blood as the source
material [refer to the source of materials for use in manufacturing;
the same hereinafter (including those for use during the
manufacturing process; the same hereinafter)] (hereinafter referred
to as “product containing human blood derived material”).
C. A period of the expiry date plus 10 years for biological products

etc. (excluding products in B).
2. In manufacturing biological preparations etc., the manufacturer shall, in addition

to the duties specified in the preceding paragraph, have the manufacturing control
manager perform properly the following duties related to the manufacturing
control of biological products etc. in accordance with the product master formula,
the manufacturing control standard code, or the manufacturing hygiene control
standard code.


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DRUMBEAT
Concept
A. When source materials or products are inactivated, or 5.28
microorganisms etc. contained in the source materials and products
are inactivated or eliminated, during the manufacturing process, to
take action necessary for preventing contamination by the source
materials or products that are inactivated or eliminated in such a
way.
B. When biochemical technology such as fermentation etc. is applied 5.12

during the manufacturing process, to perform continuous
measurements of temperature, hydrogen ion index, etc. necessary
for the control of manufacturing process.
C. When equipment for column chromatography is used during the 5.28

manufacturing process, to take action required to prevent
contamination of the equipment by microorganisms, and to
perform measurements of endotoxins, where necessary.
D. In employing the culture method to provide a continuous supply of

culture media to an incubation tank and to perform a continuous
discharge of liquid media during the manufacturing process, to
take action required to maintain incubation condition in the
incubation tank during the incubation period.
E. To restrict as much as possible for personnel other than those who 12.02.09
are engaged in manufacturing to go in or out of the work area.
F. To perform the following duties related to the sanitation and

hygiene of personnel.
(i) To restrict as much as possible for personnel to go in our 12.02.09

out of the aseptic area or the clean area where actual
operations are carried out.
(ii) To have personnel engaged in manufacturing not assign to 1.12.02

the position to keep use animals (excluding those for use in
manufacturing).
G. To perform the following duties related to the sanitation and

hygiene of personnel working in the aseptic area or in the clean
area:

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DRUMBEAT
Concept
(i) To have personnel engaged in manufacturing wear work 1.12.02
clothes, shoes, caps and masks that have been disinfected. 12.02.05
12.02.06
(ii) To have personnel undergo medical checkups at intervals 12.02.11

not exceeding 6 months in order to confirm that they do not
have diseases that are suspected to contaminate raw
materials or products by microorganisms etc.
(iii) When personnel having their conditions that are suspected 12.02.02
to contaminate raw materials or products with abnormal
numbers or types of microorganisms (including infectious
diseases such as skin or hair, cold, wound, or symptoms
such as diarrhea or fevers without causes), to have each
personnel notify the fact.
H. In addition to breeding use animals (limited to those for use in 6.27

manufacturing; the same hereinafter) under constant, proper care,
to take care not to use animals with infectious diseases or animals
not appropriate for use in manufacturing through observations of
their physical conditions before use.
I. To dispose of all the things (limited to those contaminated during 1.19

the manufacturing process) and animal carcasses that have been
contaminated by microorganisms so as not to cause hazards to the
public health and hygiene.
J. To prepare the following records in handling of microbial strains 8.01.01

for use in manufacturing, and to retain the records thereof for 5
years from the date of preparation (when the drug related to the
records is a specified product or a product containing human blood
derived material, a period of the expiry date plus 30 years, or when
the drug related to the records is a different biological product etc.,
a period of the expiry date plus 10 years).
(i) Name of microorganisms and number given to each

container.
(ii) Date of being transferred and, name and address of a

person who has transferred (in case a corporation, name
and address).

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DRUMBEAT
Concept
(iii) Biological properties and date of testing.
(iv) Status of subculture.
K. In manufacturing other products, to prohibit to use the 5.28.01

equipment/instruments of the work room for treating small pox
viruses, acute poliomyelitis viruses, spore-forming pathogens or
Mycobacterium tuberculosis, with the labels attached to them for
each type of product.
L. For materials derived from organisms (excluding plants) for use in

manufacturing of biological products (hereinafter referred to as
“biologically derived source material”, the manufacturer shall
confirm that the biologically derived source material is an
appropriate article by reference to the product master formula of
the drug, prepare records of the confirmation results, and retain the
records thereof for the following periods.
(i) A period of the expiry date plus 30 years for specified biological 8.01.01
products or for products containing human blood derived material.
(ii) A period of the expiry date plus 10 years for biological products 8.01.01
(excluding products indicated in (i)).
M. The manufacturer shall retain herself/himself records of

biologically derived source materials for use in manufacturing of
biological products for the following periods as specified by the
Minister, or close a contract with a person collecting materials of
the biologically derived source material (hereinafter referred to as
“source material collecting firm etc.”), and the records shall be
retained appropriately by the source material collecting firm etc.
based on the contract.
(i) A period of the expiry date plus 30 years for specified biological 8.01.01
products or for products containing human blood derived material.
(ii) A period of the expiry date plus 10 years for biological products 8.01.01
(excluding products indicated in (i)).
(2) To prepare records specified in Item 4 of the preceding paragraph and L 8.01
and M indicated in the preceding item from each lot of intended biological
products etc., and to retain the records thereof.

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DRUMBEAT
Concept
3. In manufacturing cellular/tissue based drugs, the manufacturer shall, in addition
to the duties in Paragraph 2, have the manufacturing control manager perform
properly the following duties related to the manufacturing control of
cellular/tissue based drugs in accordance with the product master formula, the
manufacturing control standard code, or the manufacturing hygiene control
standard code.

A. In handling of the cells or tissues collected from different donors 5.28

or donor animals, to take necessary action to prevent mixture and
cross-contamination of the cells or tissues.
B. To confirm from records on the following matters that cells or

tissues as source materials are appropriate articles, when received,
by reference to a drug master formula of the drug, and to prepare
records of the confirmation results.
(i) Facilities where the cells or tissues have been collected;
(ii) Date on which the cells or tissues have been collected;
(iii) When the cells or tissues are derived from humans, the
status of diagnosing donors through their health checking
and testing for the donor screening (refer to a decision of,
from the results of the health checking and testing of
donors, whether or not such donors are fully eligible to
provide their cells or tissues as source materials of
cellular/tissue based drugs.
(iv) When cells or tissues are derived from animals, the status
of receiving donor animals, as well as conditions of the
inspection and testing, and breeding and keeping of such
animals for the donor screening (refer to a decision of,
from the results of the health checking and testing of donor
animals, whether or not such donors are fully eligible to
provide their cells or tissues as source materials of
cellular/tissue based drugs).
(v) Records of collecting the cells or tissues.

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DRUMBEAT
Concept
(vi) Requirements for ensuring the quality of cellular/tissue
based drugs, in addition to those indicated in (i) to (v)
above.
C. In collecting cells or tissues as source materials from donor

animals, to take necessary action to prevent contamination by
microorganisms during the collection, and to prepare records of
the action taken.
D. When personnel meet any of the following conditions, not to have

the personnel work in the clean area or in the aseptic area.
(i) When personnel have their physical conditions suspected to 12.02.02

contaminate source materials or products with abnormal
numbers or types of microorganisms (including infectious
diseases of the skin or the hair, cold, wound, or symptoms
of diarrhea or fevers of unknown causes)
(ii) When personnel treat microorganisms etc. suspected to

contaminate cells or tissues immediately before their
collection or processing.
E. For products, to grasp, for each product, the name of the 7.02
destination facilities and date of distribution, and lots, and to
prepare the records thereof.
F. For distribution, to take necessary action to ensure the quality of 7.02

products, and prepare records of the action taken.
G. To prepare records of breeding and keeping donor animals after 6.27

their acceptance.
(2) To prepare records specified in B, C, E, F and G of the preceding item by 8.01.01

lot (by product for records in E of the same item), and to retain the records
thereof for a period of the expiry dates plus 10 years from the date of
preparation (a period of the expiry date plus 30 years when a drug related
to the records is a specified biological product or a product containing
human blood derived material).

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DRUMBEAT
Concept
4. Records of biological products specified in the preceding three paragraphs shall 8.01.01
be retained appropriately so as to confirm a series of records biologically derived
source materials provided in manufacturing to a product manufactured with the
biologically derived source materials.
Section 3 Quality Control

(Quality Control Standard Code)
Article 7 The manufacturer shall prepare, at each manufacturing site, a quality control 6.01
standard code describing methods of collecting samples and of evaluation test results, 6.07
and other necessary matters.
(Duties of Quality Control Manager)

Article 8 The manufacturer shall have the quality control manager perform 13.06
systematically and appropriately the following duties related to the quality control of
drugs in accordance with the product master formula or the quality control standard code.
(1) To perform by herself/himself or, according to the type of duties, to have a

A. To collect samples of raw materials and products by lot, and those 3.03
of labeling and packaging materials by control unit, and to prepare 6.01
the records thereof. 6.01.05
B. To perform the inspection and testing of the collected samples by 6.02

lot or by control unit, and to prepare the records thereof. Proviso:
This provision shall not apply so long as the following inspection
and testing are performed on the manufacturer’s own
responsibilities using the following testing facilities or institutions
without causing hindrance to the proper testing.
(i) Inspection and testing of drugs undergoing only

repackaging: Other testing institutions.
(ii) Inspection and testing of raw materials, and labeling and

packaging materials: Other testing facilities of the
manufacturer or the testing institutions specified under
Article 11, Paragraph 1 of the Enforcement Regulations of
the Pharmaceutical Affairs Law (MHW Ministerial
Ordinance No. 1, 1961; referred to as “the Enforcement
Regulations” in (iii)”).

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DRUMBEAT
Concept
(iii) High level physicochemical and animal tests of the
product: Other testing facilities of the manufacturer, or the
testing institutions specified under Article 11, Paragraph 1
of the Enforcement Regulations.
(iv) Inspection and testing of the product [excluding the

inspection and testing in (iii)]: Other testing facilities of the
manufacturer.
C. To store a reserve sample, under proper conditions of storage, 6.03

from each lot of product (in the case of specified biological
product not constituting a lot, for biologically derived source
material which has been provided in manufacturing of the product,
for each manufacturing number of the product or from each lot of
the biologically derived source material), consisting of at least
twice the quantity needed for all the required tests, for the
following periods from the date of manufacturing. Proviso: This
provision shall apply neither to drugs under a contract, already
closed between the manufacturer and a source material collecting
firm etc., specifying that the source material collecting firm etc.
shall store a reserve sample for the following periods nor to drugs
not constituting a lot other than specified biological products. For
specified biological product constituting a lot or cellular/tissue
based drugs, after three years have passed [when a drug as the
product is obliged to bear an expiry date, a period of the expiry
date plus one year (one month for radiopharmaceuticals)], storage
of the biologically derived source material which has been
provided in manufacturing of the product may be substituted for
storage of the product.
(i) Three years for drugs other than specified biological

products or cellular/tissue based drugs [when a drug as the
product is obliged to bear an expiry date, a period of the
expiry date plus one year (plus one month for
radiopharmaceuticals)].
(ii) A period of the expiry date plus 10 years for specified

biological products.
(iii) Appropriate duration of cellular/tissue based drugs

(excluding products in (ii)).

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DRUMBEAT
Concept
D. To perform the periodical inspection for maintenance of the testing 2.02
facilities and equipment (including calibration of meters), and to 2.02.04
prepare the records of the inspection. 6.12
E. Other necessary duties.
(2) To report evaluation of test results in writing to the product security 6.16
pharmacist and the manufacturing control manager.
(3) To retain records of test results for the following duration from the date of 8.01.01
preparation.
A. Three years for drugs other than biological products etc. [when the
drug related to the records is obliged to state the expiry date, a
period of the expiry date plus one year].

products etc. (excluding products indicated in B).
2. In manufacturing biological preparations etc., the manufacturer shall, in addition

to the duties in the preceding paragraph, have the quality control manager
perform appropriately the following duties related to the quality control the
biological preparations etc. in accordance with the product master formula or the
quality control standard code.
(1) To perform herself/himself or, according to the type of duties, to have a

A To separate samples by the proper labeling of identification in 5.28

order to prevent mixture and cross-contamination of the samples.
B. To perform, at the proper stage of manufacturing, the inspection 5.12

and testing required from the quality control and impracticable in 6.02
the product.
C. In addition to breeding of use animals (limited to animals for use 6.27

in the inspection and testing; the same in this paragraph), under
constant, proper conditions, to take care not to use animals with
infectious diseases and other animals inappropriate for use through
observations of their physical conditions before use.

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DRUMBEAT
Concept
D. To dispose of all the articles which have been contaminated with 1.19
microorganisms (limited to those contaminated during the
inspection and testing) and carcasses of use animals so as not to
cause hazards to the public health and hygiene.
E. To prepare the following records in handling of microbial strains 8.01.01

for use in inspection and testing, and to retain the records thereof
for 5 years after the date of preparation (when a drug related to the
records is a specified biological product or a product containing
human blood derived material, a period of the expiry date plus 30
years, or when a drug related to the records a different biological
product etc., a period of the expiry date plus 10 years).
(i) Name of microorganisms and number given to each

container.
(ii) Date of being transferred, and name and address of a

person who has transferred (in the case of a corporation,
name and address).
(iii) Biological properties and date of testing.
(iv) Status of subculture.
(2) To prepare and retain records specified in Item 3 of the preceding

paragraph from each lot of the intended biological preparation.
3. In manufacturing cellular/tissue based drugs, the manufacturer shall, in addition 13.06

to the duties specified in the Paragraph 2, have the quality control manager
perform the following duties related to the quality control of cellular/tissue based
drugs in accordance with the product master formula or the quality control
standard code.
(1) To perform by herself/himself the inspection and testing of donor animals 6.27
at the time of or after their receipt and other necessary duties, or to have a
person, designated beforehand, perform the following duties according to
the type of duties (when the drug related to the records is a specified
biological product or a product containing human blood derived materials,
a period of the expiry date plus 30 years).

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DRUMBEAT
Concept
(2) To prepare records of the duties in the preceding item, and to retain the 8.01.01
records thereof for a period of the expiry date plus 10 years (when a drug
related to the records is a specified biological product or a product
containing human blood derived material, a period of the expiry date plus
30 years.
4. Records of biological products specified in the preceding three paragraphs shall 8.01
be retained appropriately so as to confirm a series of records from biologically
derived source materials provided in manufacturing to a product manufactured
with biologically derived source materials.
Section 4 Other Duties Related to Manufacturing Control and Quality Control

(Operating Procedures for Validation etc.)
Article 9 The manufacturer shall prepare, at each manufacturing site, written operating 1.06
procedures for validation, complaint management, recall action, self-inspection, and 1.15
training (hereinafter referred to as “operating procedures”), in order to perform properly 1.16
the duties specified under Articles 10 to 14 inclusive. 1.17
1.18
2.05
5.06
5.16
6.12
6.13
7.05
8.03
(Validation)
Article 10 The manufacturer shall have a person, designated beforehand, perform the
following duties in accordance with the operating procedures.
(1) To perform validation in the following cases.
A. When manufacturing of drugs is started at the manufacturing site. 5.16
B. When there are changes made in the operating procedures, which 5.04.01
might have serious effects on the quality of drugs.
C. When it is considered necessary to perform properly the 5.16

manufacturing control and quality control of drugs.
(2) To report in writing to the product security pharmacist the results of 17.04
validation.

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Concept
(3) To retain records of validation for the following periods from the date of 8.01.01
preparation.
A. Three years for drugs other than biological products etc.

products or products containing human blood derived material.

etc. (excluding products indicated in B).
2. The manufacturer shall take all the required action when it is found necessary to 8.01.01
improve the manufacturing control and quality control from the results of the
validation in Item 1 of the preceding paragraph, prepare records of the action
taken, and to retain the records thereof for the following periods from the date of
the preparation.
(1) Three years for drugs other than biological products etc.
(2) A period of the expiry date plus 30 years for specified biological products
or products containing human blood derived material.
(3) A period of the expiry date plus 10 years for biological products etc.
(excluding products indicated in the preceding item).
(Complaint Management)
Article 11 When there is a complaint regarding the quality etc. of drugs, the 6.13
manufacturer shall have the product security pharmacist perform the following duties in
accordance with the operating procedures, excluding cases where the complained matter
is not obviously attributable to the manufacturing site.
(1) To investigate into the cause of the complaint, and to take all the required 6.21.06
action when it is found necessary to improve the manufacturing control
and quality control.
(2) To prepare records of the complaint management describing the details of 6.13
the complaint, clarified cause, and the correction action taken, and to 8.01.01
retain the records thereof for the following periods from the date of
preparation.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept

(Recall Action)
Article 12 The manufacturer shall, when taking a recall action for the reason the quality 7.05
etc. of drugs, have the product security pharmacist of the manufacturing site perform the
following duties in accordance with the operating procedures, excluding cases where the
recall is not obviously attributable to the manufacturing site.
(1) To investigate into the cause of the recall, and to take all the required 6.21
action when it is found necessary to improve the manufacturing control
and quality control.
(2) To store by separation of the recalled products for a given period, and to 7.04.02
properly dispose of them.
(3) To prepare records of the recall action taken describing the details of the 7.05.01
recall, clarified cause, and the correction action taken, and to retain the 8.01.01
records thereof for the following periods from the date of preparation.


(Self-inspection)
(1) To perform the periodical self-inspection of the manufacturing control and 6.12
quality control of drugs at the manufacturing site.
(2) To report the results of the self-inspection in writing to the product

security pharmacist.

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Concept
(3) To prepare records of the self-inspection results, and to retain the records 8.01.01
thereof for the following periods from the date of the preparation.


2. The manufacturer shall take all the required action when it is found necessary to 6.12
improve the manufacturing control and quality control from self-inspection 8.01.01
results in Item 1 of the preceding paragraph, and prepare records of the action
taken, and to retain the records thereof for the following periods from the date of
preparation.
(1) Three years for drugs other than biological products etc.
(2) A period of the expiry date plus 30 years for specified biological products
or products containing human blood derived material.
(3) A period of the expiry date plus 10 years for biological products etc.
(excluding products indicated in B).
(Training)
(1) To conduct systematically training of personnel regarding the 5.06

manufacturing control and quality control.
(2) To report the status of the training in writing to the product security 5.06.03
pharmacist.
(3) To prepare records of the training, and to retain the records thereof for 3 5.06.03
years from the date of preparation. 8.01.01
2. In manufacturing biological products etc., the manufacturer shall, in addition to

the duties specified in the preceding paragraph, have a person, designated
beforehand, perform the following duties in accordance with the operation
procedures.

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DRUMBEAT
Concept
(1) To conduct training of personnel engaging in the manufacturing or inspection and 5.06
testing of biological products etc. in microbiology, medicine, veterinary medicine,
etc.
(2) To conduct training of personnel working in the aseptic area or other areas where 1.12.02
pathogenic microorganisms are treat, for taking action to prevent contamination 5.06.05
by microorganisms.
Section 5 Manufacture at Two or More Manufacturing Sites

(Manufacture at Two or More Manufacturing Sites)
Article 15 One manufacturer (hereinafter referred to as “contractor”) who commissions 14.01
part of the manufacturing process to another manufacturer (hereinafter referred to as the
“contract acceptor”) shall close a contract with the contract acceptor regarding the
following matters in order to ensure the proper conduct of manufacturing control and
quality control during the manufacturing process.
(1) Scope of the commissioned process
(2) Technical conditions for the manufacture covered by the contract

(hereinafter referred to as “contract manufacture”).
(3) Periodical confirmation by the contractor of the proper conduct of the 14.01.03
contract manufacture at the manufacturing site of the contract acceptor.
(4) Instructions of the contractor given to the contract acceptor with respect to
the contract manufacture.
(5) When the contractor gives instructions specified in the preceding item that
any necessary action should be taken to improve the manufacturing
control or quality control of the contract manufacture, confirmation by the
contractor that such action has been taken.
(6) A method of quality control during transportation/delivery.
(7) Other matters required to ensure the proper conduct of the manufacturing
control and quality control of the contract manufacture.

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DRUMBEAT
Concept
2. The contractor and the contract acceptor shall document matters for the contract 14.01.02
specified in the preceding paragraph in the product master formula,
manufacturing control standard code, manufacturing hygiene control standard
code, quality control standard code, and operating procedures. Proviso: In such
cases, each of the contractor and the contract acceptor should document only the
processes performed by herself/himself, notwithstanding the provisions of Article
4, 5, 7, and 9.
3. The contractor shall give written instructions specified in Paragraph 1, Item 4. 14.01
4. The contract acceptor shall report in writing to the contractor that the security 14.01.02
pharmacist of the contract acceptor has released the products through appropriate
evaluation of the manufacturing control and quality control of the contract
manufacture.
5. The contractor shall have a person, designated beforehand, perform the following
duties.
(1) To obtain confirmation specified in Paragraph 1, Items 3 and 5.
(2) To report in writing to the product security pharmacist of the contractor

the confirmation results in the preceding item.
(3) To prepare records after the date of expiration specified in Item 1, and to 8.01.01
retain the records thereof for the following periods after the date of
preparation.


Article 15-2 The contractor may provide instructions, instead of written instructions 14.01
specified in Paragraph 3 of the preceding article, by using an electronic system of
information processing or by the following methods utilizing information
communication technologies (hereinafter referred to as “electromagnetic methods” in this
article) after having obtained the consent of the contract acceptor as specified in
Paragraph 4. In such cases, it shall be recognized that the contractor has provided written
instructions.

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Concept
(1) The following method A or B among the methods of using an electronic 2.06.03
system of information processing shall be used.
A. The method to transmit instructions through an electric

communication line connected between the user computer of the
contractor and the user computer of the contract acceptor, and to
enter in the files equipped with the user computer of the
destination.
B. The method to provide, through an electric communication line,

the contract acceptor with direct access to the instructions entered
in the files equipped with the user computer of the contractor, and
to enter in the files equipped with the user computer of the contract
acceptor (when the contract acceptor provides consent or rejection
as to whether to obtain instructions by electromagnetic methods,
the method to enter the consent or the rejection in the files
equipped with the user computer of the contractor.
(2) The method to distribute instructions entered in the files prepared with 2.06.03
means capable of providing a safe entry to given matters, including a
magnetic disk, CD-ROM or other equivalent means.
2. The methods specified in the preceding paragraph shall allow the contract
acceptor to prepare a document by output of data entered in the files.
3. The term “electronic system of information processing” used in Paragraph 1, Item

1 means an electronic system of information processing, which connects, through
an electronic communication line, the user computer of the contractor with the
computer of the contract acceptor.
4. The contractor shall, when intending to give instructions specified in Paragraph 3

of the preceding article pursuant to the provisions of Paragraph 1, present the
following matters to the contract acceptor beforehand, and obtain the consent of
the contract acceptor in written or by electromagnetic methods.
(1) The method available to the contractor among the methods specified in
Paragraph 1.
(2) The method to enter in computer files.

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Yakuji Nippo, Ltd.
DRUMBEAT
Concept
5. When the contractor obtaining the consent specified in the preceding paragraph is
informed in written or by the electromagnetic methods that the contract acceptor
refuses to obtain instructions by electromagnetic methods, the contractor shall not
give instructions specified in Paragraph 3 of the preceding article by
electromagnetic methods. Proviso: This provision shall not apply when the
contract acceptor has given the consent specified in the preceding paragraph.
6. The provisions of Paragraphs 1 to 5 inclusive shall apply mutatis mutandis to the

written report specified in Paragraph 4 of the preceding article. In such cases,
“contractor” in these provisions shall read “contract acceptor”, and “contract
acceptor” shall read “contractor”.
Article 16 When the manufacturing process is performed at two or more manufacturing

sites of the manufacturer, the manufacturer shall establish methods of quality control
during transportation/delivery, and other necessary matters required to ensure the proper
conduct of the manufacturing control and quality control of the manufacturing process.
2. The manufacturer shall document the matters established in the preceding

paragraph in the product master formula, the manufacturing control standard
code, the manufacturing hygiene control standard code, the quality control
standard code and in the operating procedures. Proviso: In such cases, each of the
contractor and the contract acceptor should document only the matters on the
process performed by herself/himself, notwithstanding the provisions of Articles
4, 5, 7 and 9.
Section 6 Miscellaneous Provisions

(Exceptions in Retention of Records)
Article 16-2 Notwithstanding the provisions of Article 6, Article 8, Article 10 to Article 8.01.01
13 inclusive, and Article 15, the manufacturer or the contractor shall have the
manufacturing control manager, the quality control manager or a person, designated
beforehand, retain records specified under Article 6, Article 8, Article 10 to Article 13
inclusive, and Article 15 of biological products designated by the Minister for the periods
specified by the Minister. Proviso: This provision shall not apply to cases where a
contract has been closed between the manufacturer or the contractor and a source
material collecting firm etc. for the relevant period based on the contract.

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Yakuji Nippo, Ltd.
Chapter 3 Manufacturing Control and Quality Control of Quasi-drugs
DRUMBEAT
Concept
(Manufacturing Control and Quality Control of Quasi-drugs)
Article 17 The provisions in Chapter 2 (excluding Article 4, Item 3; Article 6, Paragraph
2; Article 8, Paragraph 2; and Article 14, Paragraph 2) shall apply to quasi-drugs. In this
case, “product security pharmacist (hereinafter referred to as “product security
pharmacist”) under Article 2, Paragraph 1 shall read “responsible engineering manager”,
and “product security pharmacist” in Chapter 2 (excluding Article 2, Paragraph 1) shall
read “responsible engineering manager”.
DRUMBEAT
Concept
(Date of Enforcement)
1. This ordinance shall come into effect on March 31, 1999.

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The Japanese GMP Regulations 2003

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The Japanese GMP Regulations 2003 2 December 2004

Yakuji Nippo, Ltd.

I. Regulations for Buildings and Facilities of Pharmacies etc.

(MHW Ministerial Ordinance No. 2 dated February 1, 1961;

Chapter 2 Manufacture of Drugs etc. (Articles 5 - 14-4)

Chapter 2 Manufacture of Drugs etc.

(2) The area for manufacturing operations (hereinafter referred to as “work

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

B. To be distinctly separated from living quarters and other 9.02

C. To have an adequate area for operations to be performed. 9.01

E. To have floors made of wood, concrete or equivalent materials. 9.07

F. To have facilities or equipment for the disposal of sewage and 1.19.01

G. To have disinfection facilities for personnel. 9.06

H. To have facilities for the disposal of poisonous gases if generated 9.03

A. Work tables in the work room shall be constructed so as not to 9.07

B. To be constructed so as not to allow passage for personnel other 11.01

D. To have ceilings made of wood, concrete or materials equivalent 9.07

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

F. To have pipes and ducts in the room constructed so as to prevent 9.07.02

(2) To be appropriately positioned so as to facilitate the smooth and proper 9.01

(3) Work areas shall meet the following requirements.

A. To be adequately lighted, illuminated, ventilated and cleaned. 9.03.01

B. To be distinctly separated from living quarters and other 9.02

C. To have an adequate area for performing the operations. 9.01

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

E. To have facilities or equipment for the disposal of sewage and 1.19.01

F. To have disinfection facilities for personnel. 9.06

G. To have facilities for the disposal of poisonous gases, if generated 9.03

I. When a drug which is easily dispersed and causes anaphylaxis in 5.28

J. To have washing and toilet facilities and dressing rooms. 9.06

(i) Work tables in the work room shall be constructed so as 9.07

(ii) To be constructed so as not to allow the passage of 11.01

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

(v) Water discharging facilities in the room shall be 9.07.01

A. Inspection and testing of drugs undergoing only repackaging:

B. Inspection and testing of raw materials, and packaging and

C. High level physicochemical or animal tests of drugs: Other testing

D. Inspection and testing of products, excluding the tests in C: Other

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

(2) To be properly positioned so as to facilitate the smooth and proper 9.01

A. To be adequately lighted, illuminated, ventilated and cleaned. 9.03.01

B. To be distinctly separated from living quarters and other 9.02

C. To have an adequate area for performing operations. 9.01

E. To have facilities or equipment for the disposal of sewage and 1.19.01

F. To have disinfection facilities for personnel. 9.06

G. To have facilities for the disposal of poisonous gases if generated 9.03

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

B. When a drug which is easily dispersed and causes anaphylaxis in 5.28

(i) Work tables in the work room shall be constructed so as 9.07

(ii) To be constructed so as not to allow the passage of 11.01

(iii) To have no entrances or exits opening directly to the 11.01

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

(v) The water discharging facilities in the room shall be 9.07.01

A. Inspection and testing of drugs undergoing only repackaging:

B. Inspection and testing of raw materials, and packaging and

C. High level physicochemical or animal tests of drugs: Other testing

D. Inspection and testing of products (excluding the tests in C) Other

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

(1) Work areas shall meet the following requirements.

© 2004 Drumbeat Dimensions, Inc. DRUMBEAT DIMENSIONS, INC.

(iii) To have facilities and equipment that allow sterilization 9.01

E. To have dressing rooms for exclusive use by personnel engaging 9.06

(2) Work areas shall be provided with the following facilities.