PRESENTED BY:

Rohit Mansikumari Natubhai

M.Pharm, SEM-1 (Qa Department)
SSRMPH14
 According to FDA a drug is defined as adulterated if the
methods use in its manufacture or processing, testing,
packaging, storing did not conform to the GMPS.
 As a result of this, GMPs were first established in june
1963.
 Drugs being a very important component of health care
system need special attention in regard to their quality,
safety, efficacy.
 Final testing of the product cannot ensure the quality,
safety, efficacy of a product.
 Therefore the concept of Qc evolved and the
development of Qc resulted in GMPs.
 Many Indian drug manufacturers export
pharmaceutical preparation to other member
countries of WHO.
 Indian drug manufacture as well as their technical
personnel should be aware of the GMP guidelines
prepared by WHO. These are referred to WHO
GMPs.
 WHO define Good manufacturing Practice (GMP) as
“that part of quality assurance which ensure the
products are consistently produced and controlled
to the quality standards appropriate to their
intended use and as required by the marketing
authorization.
 GMP covers all aspects of the manufacturing
process:
 Defined manufacturing process
 Validated critical manufacturing steps
 Suitable premises
 Storage and transport
 Qualified and trained production and quality
control personnel
 Adequate laboratory facilities
 Approved written procedures and instructions
 Records to show all steps of defined procedures
taken
 Processing and distribution records
 Systems for recall and investigation of complaints.
 A poor quality medicine may contain toxic substance
that have been unintentionally added.
 A medicine that contain little or none of claim will not
have the therapeutic effect.
 Poor quality medicines are not only a health hazard, but
a waste of money for both governments and individual
consumers.
 GMP helps boost pharmaceutical export opportunities.
 Governments seeking to promote their countries export
of pharmaceuticals can do so by making GMP
mandatory for all pharmaceutical production and by
training their inspectors in GMP requirements.
Ensure products are safe for humans

Reduce the risk of mislabeling and adulteration

Helps to reduce observation raised on inadequate

documentation practices.
Help prevent and control contamination and cross
contamination
Promotes efficiency and reduce the cost of doing
business
1. Writing step-by-step operating procedures and
work instructions.
2. Following written procedures and instruction at all
times to prevent contamination, mix-ups and
errors.
3. Documenting work accurately and in a timely
fashion.
4. Proving that systems do what they are designed to
do by validating equipment system and processes.
5. Designing and constructing facilities and
equipment.
6. Monitoring and maintaining facilities and
equipment.
7. Defining, developing and demonstrating job
competence.
8. Protecting against contamination and maintain a
clean environment.
9. Controlling raw materials, components and
product related processes.
10. Conducting planned and periodic audits.
 Stress the importance of written procedure.
 The best way to comply with GMP is to have well
written procedure and carefully following them.
 Give us the necessary to minimize the chance of
contamination, mix-ups and errors.
 Documentation is the key to operating a
pharmaceutical company in compliance with GMP
requirements. The system of documentation devised or
adopted should have as its main objective to establish,
monitor, and record “Quality” for all aspects of the
production and quality control.
 Several type of documents are need to accomplish this.
 Standard operating procedure, specification and master
formula.
 Forms for recording data.
 Identification numbers.
 Labels.
 Any document that can impact the quality of the
product or product safety is treated as a controlled
document. Example : policies , SOPs, specifications ,
MFR (master formula record )
 The accuracy and content of these documents can
be subject to review by regulatory bodies including
the FDA.
 Validation:
 Proactive proof that we can produce safe and
effective products.
 Requires a series of test to assure our systems do
what we say they do.
 Give meaning to documentation we make.
 Tells us written procedure are correct and our
products are truly safe.
 Key concern of principle 5 & 6: Avoid the possibility
of contamination, mix-up and errors in work place.
 Keeping certain areas such as cafeteria, restroom
and locker room separated from manufacturing
area.
 Water, air, temperature and humidity should be
controlled in order to avoid mix-ups and errors.
 GMP requires competent personnel who perform
the job right every time.
 Personnel should be properly trained.
 Company must have formal training program to
assure each employee can competently perform
assigned job.
 Focus on cleanliness and requires us to constantly be
on-guard to defend our product against contamination.
a) Particular contamination: Product has been made
impure by any particle that does not belong in it.
Examples: Dust, dirt, hair.
b) Microbial contamination: Caused by microscopic
organisms that are living organism that exist on
everything in environment that is not sterilized.
Example: fungus, mold, bacteria and virus.
c) Cross contamination: Occurs when traces of other
materials, components and products adulterate or
miss brand a product that we are currently
manufacturing or testing.
 Material and
Manufacturing process Packaging and labeling Testing
components
• Satisfy our quality • Master records that • Inspect packaging • Supports all other
standards. outline specification and labeling area areas of control.
• Upon receipt must be and manufacturing before each new • Must be performed
carefully examine for procedures. batch is processed. by the qualified
damage and • Individual batch or • Packaging equipment individuals.
contamination. history records to is clean and the area • Assures the safety,
• Certain components help to document the does not contain any effectiveness and
and materials must conformance to materials form purity of product as
be sampled and master record. previous run. they enter
tested to ensure that • Written schedules marketplace.
they meet the and procedures for
established identity, cleaning and
quality and purity. maintaining
• After approval they equipment.
are released to
manufacturing and
used on first in first
out basis.
 FDA has major responsible to externally audit
manufacturing operation to see if we are in
compliance with cGMP regulation.
 FDA has the responsible to protect the consumer
and can recommend a recall product if a product is
contaminated, miss-labeled or is not manufacture
in compliance with cGMP regulations.
 Company has the responsibility to internally ensure
the integrity of products.
 Avoidance of cross-contamination
 Prevention of mix-ups
 Provide traceability
 Accountability of actions
 Responsibility
 Product performance guarantee