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Angelyka Cabalo 2A PH (2016-2017)

PharDose Chapter 3
Current Good Manufacturing Practices and Current Good
Compounding Practices
Common Terms used by cGMP for finshed pharmaceuticals
1. API Active Pharmaceutical Ingredient is any
component intended to furnish phamocological
activity or a direct effect on the diagnosis, cure ,
mitigation of a disease,
2. BATCH a specifc qty of a drug of uniform quality
produced accdg to a single manufactiuring order
3. BATCHWISE CONTROL
4. CERTIFICATION
5. COMPLIANCE
6. COMPONENT
7. DRUG PRODUCT
8. LOT
9. LOT NUMBER
10. MASTER RECORD
11. QUALITY ASSURANCE
12. QUALITY AUDIT
13. QUALITY CONTROL
14. QUALITY CONTROL UNIT
15. QUARANTINE
16. RERESENTATIVE SAMPLE
17. REPROCESSING
18. STRENGTH
19. STRENGTH
20. VERIFIED
21. VALIDATION
22. PROCESS VALIDATION
23. VALIDATION CONTROL
The organization and personnel section require that a
quality control unit have the authority and responsibility
for all functions like accepting or rejecting product
components, specifications, finished products, packaging
and labeling
All personnel have the training, education and/or
experience
Building and Facilities structure , spaces, design must be
such to enable thorough cleaning, inspection, safe and
effective use of equipment. Factors such as water quality,
security on materials, separate areas for quarantine,
rejected materials, for quality approval, for weighing, etc
EQUIPMENT - Each piece must be of appropriate design ,
size and location with written standard operating
procedures
CONTROL OF COMPONENTS. CONTAINERS AND CLOSURES
1. Received components must be logged with
purchase order number, date, bill of lading,
name of supplier and qty
2. Assign a control number for identification and is to
be followed throughout the production for tracing
PRODUCTION AND PROCESS CONTROLS
Written procedures on charge-in of all components, use of
in-process controls, sample testing and process and
equipment validation. The operator records date and time
of each key operations. Products are labeled as to
contents and status. In-process samples are taken to
ensure that the machinery is producing output within preestablished control limits
PACKAGING AND LABELING CONTROLS
1. Labeling of drugs on strength, dosage form, qty
mut be stored with proper identification

2.

Materials for packaging must be approved and


released by quality control unit, labeling facilities
must be inspected before use
3. There must be an appropriate electronic eqpmt to
conduct 100% examination for correct labeling
and the examnation must be performed by one
person then independently verified by another
person.
4. Lables must meet legal requirements for content,
expiration dating, production batch or lot number
TAMPER EVIDENT PACKAGING
to improve security of OTC drugs and assure
effectiveness and safety. A tamper-evident package is
one having one or more indicators or barriers to
entry which if breached or missing can reasonably be
expected to provide visible evidence to consumers
that tampering has occurred.
HLDING AND DSTRIBUTION written procedures on how
the products are quarantined on storage, shipped under
conditions that do not affect quality. The distribution
control system must allow that the distribution point of
each lot of drug product be readily determined to
facilitate recall if necessary.
RECORDS AND REPORTS
Production, control and distribution records must be
maintained for AT LEAST A YEAR following the expiration
date of a production batch. The master document in each
step was accomplished and approved by a quality control
unit. Records of written and oral complaints about the
product must be maintained and be made available at
the time of inspection of FDA.
Returned drug products must be tested and may be
salvaged. Those that are subjected to extreme
temperatures must not be returned to the market place.
Records must be maintained which includes date and
reasons of return
Information Technology and automation IS NOT PART of
cGMP requirements but can be used to enhance
pharmaceutical process development. Ex, are robotic
devices to replace manual operations.
CLINICAL TRIAL MATERIALS must be produced in
conformance with cGMP.
Non compliance with cGMP regulations can lead to a)
delay of approval of an otherwise approvable application,
in worst case, FDA may remove violative products from
the market, restrict product approvals or withdraw product
approval.
Pharmacies that engage in the manufacture, repackaging,
relabeling of drugs must register with FDA as a
manufacturer or distributor and be subject to FDA
inspection at regular intervals
Pharmaceutical manufacturing is a large scale production
of drugs for distribution whereas compounding is a
preparation of prescription for specific patients
REASONS WHY PHARMACIES HAVE INCREASED THE
PRACTICE COMPOUNDING
a) drug dosages and forms are not commercially
available
b) allergy to excipients in commercial products
c) childrens meds must be in liquids, flavored
d) must be prepared for a few days for dispensing
e) physicians request for products to be delivered in
innovative ways
f) preparation of sterile products for home use
g) for higher concentrations for pain management

h)

products not yet manufactured but have reports


on their use

CHAPTERS RELATED TO PHARMACY COMPOUNDING


.. read
PACKAGING, LABELING AND STORAGE OF
PHARMACEUTICALS
Standards for the packaging of pharmaceuticals by
manufacturers are contained in the CURRENT GOOD
MANUFACTURING PRACTICE section of the Code of
Federal Regulations (1) in the USF NF (12) and in the
FDA s Guideline for Submitting Documentation for
Packaging for Human Drugs and Biologics (13)
Qualities tested in a container are:
a) physicochemical properties
b) light transmission for glass or plastic
c) drug compatibility
d) leaching/ and or migration
e) vapor transmission for plastics
f) moisture barrier
g) toxicity for plastics
h) valve,actuator
i) sterility and permeation
j) drug stability for packaging
Dosage forms such as tablets, capsules, and oral liquids
may be packaged in a single-unit ( intended for a single
dose) or multiple unit containers .
Among the advantages cited for single unit packaging are
positive identification and reduction of medical errors,
reduced contamination, reduced dispensing time, greater
ease of inventory control and elimination of waste
The packaging materials may be combinations of paper,
foil, plastic or cellophane.
Many pharmaceutical products require light resistant
containers normally made of amber glass or light resistant
opaque materials.
Pharmaceutical manufacturers must use containers that
do not adversely affect the composition or stability of
their products. Today, most products are packaged in
plastics due to its advantages over glass such as lightness
in weight, resistance to impact, versatility in design,
consumer preference, popularity of blister packaging.
Among the problems in the use of plastic are a)
permeability to atmospheric oxygen b)leaching of the

constituents c) absorption of drugs d) transmission of light


e) alteration of the container upon storage.
PERMEABILITY process of solution and diffusion with the
penetrant dissolving in the plastic on the one side and
diffusing on the other side,
LEACHING used to describe movement of components of
a container into the contents. Temperature has influenced
also
excessive agitation and solubilizing effect of liquid
contents
SORPTION = term used to indicate the binding of
molecules to polymer materials.
, includes both adsorption and absorption
MANUFACTURERs LABEL
1. established name of the drug
2. name of the manufacturer
3. pharmaceutical type of dosage form
4. net amount of drug product contained in the
package
5. logo RX ONLY
6. label reference
7. special storage instructions
8. national drug code identification number
9. lot number
10. expiration date
11. for controlled drug substance the DEA symbol C
PRESCRIPTION LABEL
OVER-THE-COUNTER LABELING
DIETARY SUPPLEMENT LABELING
STORAGE :To ensure the stability of pharmaceutical
preparation for the period of its intended shelf life , the
product must be stored in proper conditions
Cold temp not exceeding 8 deg
Cool any temp bet 8 and 15 deg C
Room temp prevailing in work area
Warm any temp bet 30 and 40 deg C
Excessive heat above 40deg C
TRANSPORTATION shipment from manufacturer to
pharmacy

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