BASIC GMP

TRAINING

BCN
Mrs. N. Osuji

The principle of cGMP

current Good Manufacturing Practice

means making products that are always
fit for their intended use
*
The quality of healthcare products is absolutely
crucial
*
Following the procedures of cGMP at every stage
of product manufacture will ensure the correct
quality for patients
*
The product must be in a properly sealed and intact
container

 The container must be right for that product

and carry a label which displays all the correct
information about the product.
The product must be of the required quality and
strength
Free from contamination or deterioration and above
all it must be the right product
*
Testing a complete product batch is often impossible
without destroying it
*
It is essential that each sample tested must
accurately represent the whole batch
*
Quality has to be built in to every process from start to
finish

Manufacturing Process
control
Quality cannot be achieved without
rigorous control of both the process and
the people who work with it
*
It is vital that everyone obeys the rules
from their very first day at work
*
Following the S.O.P.s Standard
Operating Procedures will ensure that
everyone knows what to do and how to
do it

 Everything in the production process is subject

to a detailed specification
Each step of product manufacture is detailed in
a Batch Manufacturing Record
Operations in the packaging process are
detailed in a Packing Record
*
Operations not directly related to the
production process are generally detailed in
the general S.O.P.s

Record keeping
Batch Manufacturing and Packing Records prescribe what must
be done and record what has been done
*
Because quality is so important and mistakes so dangerous it is
essential that records are completed properly accuratelyand at
the time of eventnever later
*
All records must be signed and dated
*
If there is something you do not agree with
dont sign the recordmistakes costs lives
*
Any error on the record should be crossed through onceand once
onlynever obliterate the entry
*
If any doubtASK

The product and you

People are the greatest source of contamination in the
healthcare industry
*
Normally harmless microorganisms can have devastating
effects on a sick person if introduced via medicine, eye
drops, medical devices or cosmetics, which they may take
or use.
*
Products must be protected from these organisms
and thereforeyou
*
Personal cleanliness must be an essential part of your
everyday routine for working in a healthcare environment.

 Everyone involved must

work.dress.and..behave
correctly
Every item must be appropriately
labeled at every stage of production
Accurate records must be kept at
every stage of every activity
The quality and safety of medicines
can only be sustained by
responsible people

 Protective clothing and gloves must be worn

according to the procedures you will be taught
*
Never touch the product without wearing
the appropriate protective garments
*
Always report any illness infection or open
wound.
*
NeverNEVEReatdrinkchewor smoke
in production areas
*

Always work carefully and tidily to avoid creating

dust and spillagesdont rush

Always follow instructions precisely

*
Cultivating the right attitude to working with cGMP, will
ensure the highest quality of the product.
*
Remember the basic rule of your training is if you
don't know or are not sure ask and keep on asking
until each task is fully understood
*
If there is no one to ask dont do it!

QUESTION?

THANK YOU

UNDERSTANDING
GMP

Introduction
Medicines have to be taken entirely on
trust
Medicines, if wrongly made or wrongly
labeled may prove fatal
Only the highest quality standards must
apply in medicine manufacture
Quality is critical
Quality is controlled by
Good Manufacturing Practice
GMP

What is GMP?
The GMP definition of Quality;
``that every product must be fit for its
intended purpose
Doctors and patients must be assured
that medicines are; free from
contamination
Made to the correct formula
Have not deteriorated
Andare in the correct sealed container

 GMP is the overriding principle which

governs the quality of every aspect of
making a medicine.
To illustrate GMP it is explained as a
series of principles which includes;
Every action must be undertaken by
following written instructions
Raw materials must be stored and
handled correctly
Facilities and machinery must be
correct for their purpose.

 Quality control must be undertaken at every

stage of the manufacturing process.
All work must be undertaken
correctly..precisely.and.accurately
Contamination of materials must be avoided
at all times.
Correct labeling is carried out at every stage
of production.
Accurate records are kept at every stage of
production
Every product must be fit for its intended
use.

Documentation &
Records

Inaccurate records are

potentially very dangerous
Accurate records are the means
by which corrective action may
be taken

Documentation and
Records

To be certain that nothing is left to chance, GMP

depends on the principle that everything will be
completely documented.

Work can only be relied on to be done properly

when each step is written down clearly with no
reliance on memory or word of mouth
instructions.

This applies equally to the choice of materials to

be used and actions to be carried out.

As well as recording what has been done.

There are four groups of documents.

The first is SPECIFICATIONS.
These specify the standards or
measurable performance of materials
to be used. For example, there are
specifications for;
Raw materials.....
Packaging materials such as
containers and labels....
Machines
Environment ..etc.
And the product been made

 The second group of documents is

MANUFACTURING and PACKAGING
INSTRUCTIONS.

Here, the documents are specific to

the particular product to be made and
will detail:
Which materials are to be used...
The quantities of materials needed...
Which items of machinery or equipment
will be required and location..

 The environmental conditions and

Equipment settings..
The Line Clearance checks to be
done
The procedures and Quality checks to
be followed either to manufacture or
to package the product.
Bulk and intermediate product
storage conditions

 A batch manufacturing and a batch packaging

instruction is issued for every batch being made.
No matter how many times this has been done
before, it is essential that the new documents are
referred to each time.
In fact, to ensure that this is done, each
document has to be signed in the appropriate
place by each person involved.
The supervisor must also countersign each
significant entry

 The third group of documents is often

described as `Standard Operating
Procedures, (usually shortened to
S.O.Ps).
The name may vary from country to
country but they are all concerned with
detailing the manufacturing and
packaging activities that are not
specific to any one product.

 S.O.P.s are issued to cover the

methods to be used for
Stores operations, such as the receipt and
handling of raw materials, packaging items
and products.....
Procedures to be followed when dispensing
materials...
How to clean manufacturing or packaging
areas and equipment
What sort of clothing and other items, such as
eye protection and gloves, should be used and
how to use them ...

 How to operate the water system...

How to set-up and operate each
machine....
Even how to move materials from one
place to another....
And how to handle the problems
arising from mistakes which have been
made, either immediately, or when
complaints have been received.....
...there should be a standard operating
procedure for every eventuality

 The final group of documents is

RECORDS.
These, obviously, record what
has been done.
The important thing about
records is that they must be
kept for every single activity
and they must be made at the
time the activity is carried out.

 Not only must the detail be recorded

from :
The cleaning and preparation of
equipment ...
The issuing and receipt of materials...
The handling of containers in
quarantine...
To the completed labeling of a batch...
But this must be entered clearly and
precisely, complete with the time and
date when it was done.

 If an entry was made incorrectly then

it must be shown as such and there
should be no attempt to obliterate it.
It must be correctly dated and signed.
Inaccurate records are potentially
very dangerous.
Records are kept for very good
reasons, not the least being, that if
any problems about a particular
matter or batch should arise in the
future, the records can be referred to
and corrective action taken

Quality Assurance &

Quality Control
Quality Assurance defines the activities
undertaken to ensure that a product is fit
for its intended use.
The role of Quality Control is to verify
every activity and check the quality of
the end product
Quality Control is also necessary for
ensuring that the environment is
monitored and the process is validated
for its intended purpose

Stores And Materials

Materials from Regular suppliers cannot
be assumed to be correct
Raw materials must always be placed in
quarantine to await quality control
sampling
Correct product and material labeling is
crucial
Materials should always be moved with
great care and stored in a secure and
non-damaging way

 Detailed instructions must be

followed precisely for the mixing of
materials used in the preparation of
medicines
Thorough cleaning and sanitization
of all containers, equipment and the
environment is essential
Materials must meet the standards
detailed in the specifications

The Environment &

Machinery
Manufacturing conditions must be to a
standard which does not impair the
product
Control of environment quality is vital
for parenteral product manufacture
Medicines must contain only the
formulated ingredients
Improper cleaning of containers may
cause contamination from chemical
residues

 Sterile products must be absolutely free

of all microorganisms both living and
dead
Personnel must pay particular attention
to personal hygiene and correct
behavior at all times
Control of contamination is the major
objective in the cleaning and
disinfection of buildings and equipment
Maintenance of the environment and
production equipment is critical to the
principles of GMP

People & Training

GMP depends on people doing the right
thing.in the right way.at the right time
Training ensures that every individual knows
how to undertake their specific tasks
Particular attention must be paid to what
people wear.to protect themselves and the
product
No product should be touched without
wearing gloves and protective clothing
Eatingdrinkingsmokingthe chewing of
gum.and the taking of medicines is
prohibited in production areas

Labelling
Every product must be clearly and accurately
labelled
Identity labels indicate the product and what it
contains. They must show the batch number.the
material code number.and the date
Status labels indicate the state of progress of the
product. They must show the batch numberthe
material code numberand the date
Both identity labels and status labels are used on
the same product items
Labels must always be placed on the body of the
container.never on the lid

Conclusion
The concept of GMP is to ensure that the
risks of making mistakes is reduced to a
minimum
All activities must follow written or
documented procedures
Raw materials must be stored and
handled correctly and only the correct
materials mixed
Correct cleaning procedures for the
environment facilities and equipment
must be followed

PERSONA
L
HYGIENE

Introduction
GMP requires that everyone is trained in personal
hygiene
*
Remember that medicine must always be made
correctly
*
People are one of the great contaminators
*
Skin flakes cause contamination
*
Bacteria and microorganisms live on dead skin flakes
*
Germs live on us and in us and can cause infection in
patients
Each person is responsible for his or her own hygiene
and cleanliness

The Head

Hair must be kept clean

*
The head must be properly covered
*
Beards and mustaches must be correctly
covered
*
The nose and mouth are both danger areas
*
Dont shout try not to sneeze or cough

Good oral hygiene is very important

*
Always wear correctly fitting masks
*
Dont rub your eyes, ears or nose
*
Be aware of dangerous mannerisms

Cosmetics & Make up

Make up is a serious
contaminator

The Body

Wash regularly
*
Showers are better than
baths

The Hands

Hands are major contaminators

*
They transport contaminations and they
also harbor contamination
*
Hands must be kept totally clean
*
Pay particular attention to cuticles and
nails

Jewelry AND Health

Jewelry should not be worn
All personnel should be medically fit
*
Smoking eatingchewing and
drinking
are prohibited in production areas

SUMMARY

Think clean
Dress clean
Work clean and
Keep clean at all
times

QUESTION?

THANK YOU