WHO Good Manufacturing Practice Requirements Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.

1. WHO GMP REQUIREMENTS
DEEKSHITHA H S
DEPARTMENT OF
QUALITY ASSURANCE
MPHARM 1ST SEMESTER
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2. INTRODUCTION
• According to FDA a drug is defined as adulterated if the methods used 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. The concept was born
in U.S.A
• 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.
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3. • Many Indian drug manufacturers export pharmaceutical
preparations to other member countries of WHO.
• Indian drug manufacturers as well as their technical personnel
should be aware of the GMP guidelines prepared by WHO .
These are referred to WHO GMPs
GMP- GOOD MANUFACTURING PRACTICES .
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4. GOOD MANUFACTURING PRACTICES
• WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance
which ensures that 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, 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; full traceability of a product through batch processing
records and distribution records; and systems for recall and investigation of
complaints.
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5. WHY GMP IS IMPORTANT ?
• A poor quality medicine may contain toxic substances that have been unintentionally added.
• A medicine that contains little or none of the claimed ingredient will not have the intended 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
Most countries will only accept import and sale of medicines that have been manufactured to
internationally recognized GMP.
• 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.
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6. GMP BENEFITS
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Helps to reduce observations raised on inadequate documentation
practices.
Ensures products are safe for humans.
Helps Prevent and control contamination and cross contamination.
Reduces the risk of mislabeling and adulteration.
Promotes efficiency and reduces the cost of doing business.

7. PRINCIPLES OF GMP
1. Writing step-by-step operating procedures and work instructions.
2. Following written procedures and instructions 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 systems 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.
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8. PRINCIPLES 1&2
• Stress the importance of written procedure.
• The best way to comply with GMP is to have well written procedures and carefully following them.
• Give us the controls necessary to minimize the chance of contamination, mix-ups and Errors.
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9. PRINCIPLE 3
• 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 types of documents are needed to accomplish
this.
• Standard operating procedures, specifications and master formulae
• Forms for recording data
• Identification numbers
• Labels
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10. • Any document that can impact the quality of the product or
product safety is treated as a controlled document.
Examples of controlled document: 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.
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11. PRINCIPLE 4
• Validation:
• Proactive proof that we can produce safe and effective products.
• Requires a series of tests to assure our systems do what we say they do.
• Gives meaning to documentation we make.
• Tells us written procedures are correct and our products are truly safe.
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12. PRINCIPLE 5 &6
• Key concern of principle 5&6: Avoid the possibility of contamination, mix-ups and errors in work place.
• Keeping certain areas such as cafeteria , restrooms and locker rooms separated from manufacturing area.
• Water, air, temperature and humidity should be controlled in order to avoid mix-ups and errors.
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13. PRINCIPLE 7
• 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 preform assigned job.
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14. PRINCIPLE 8
Focuses 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 organisms that exist on everything in
environment that is not sterilized.
Examples: Fungus, mold, bacteria and viruses.
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.
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15. PRINCIPLE 9
d processes.
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Material and
Components
• Satisfy our quality
standards.
• Upon receipt must be
carefully examined for
damage and contamination.
• Certain components and
materials must be sampled
and tested to ensure that
they meet the established
identity, quality and purity.
• After approval they are
released to manufacturing
and used on first in first out
basis.
Manufacturing
Process
• Master records that
outline specifications and
manufacturing procedures.
• Individual batch or history
records to help to document
the conformance to master
record.
• Written schedules and
procedures for cleaning and
maintaining equipment.
Packaging and
Labelling
• Inspect packaging
and labeling area
before each new
batch is processed.
• Packaging
equipment is clean
and the area does not
contain any materials
from previous run.
Testing
• Supports all other
areas of control.
• Must be performed by
qualified individuals.
• Assures the safety,
effectiveness and purity
of product as they enter
marketplace.

16. PRINCIPLE 10
• FDA has major responsibility to externally audit manufacturing operations to see if we are in compliance with
cGMP regulation.
• FDA has the responsibility 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.
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17. THE AIM OF GMP
Key Provisions of GMP
• GMP
• General Provisions
• Building and facilities
• Equipment
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SAFE the product has
the right ingredients .
It is packaged as
intended and correctly
labelled in order to
provide identification
and safe use.
PURE it is free of
contaminants, foreign
matter, chemicals and
harmful microbes.
EFFECTIVE Product
requires the correct
ingredients, the correct
amount of ingredients
and correct packaging to
maintain the product
stability over time.
UNIFORM The product is
manufactured
consistently and will
have the same quality
between batches
manufactured on
different days.

18. QUALITY MANAGEMENT
• Quality management in the drug industry is discussed in the WHO GMP for Pharmaceutical Products .
In this document the following are presented:
• The basic elements of quality management are: - an appropriate infrastructure or “quality system”,
encompassing the organizational structure, procedures, processes, and resources; and - systematic
actions necessary to ensure adequate confidence that a product (or service) will satisfy given
requirements for quality. The totality of these actions is termed “quality assurance”.
• The concepts of quality assurance, GMP, and quality control are interrelated aspects of quality
management. They are of “fundamental importance to the production and control of pharmaceutical
products”.
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19. • QA encompasses all of the arrangements made to ensure that pharmaceutical
products meet the quality required for their intended use.
• Although QA is not specified in all GMP documents, the WHO GMP guidelines
present the principles of QA are to ensure that GMP and other regulatory codes
(GLP - Good Laboratory Practice, and GCP - Good Clinical Practice) are
respected; that responsibilities are clearly specified; all testing, controls,
calibrations, validations, etc are performed as specified; that products are not sold
before the correct authorizations have been obtained; that products are
appropriately handled throughout their shelf-life; and that there is a procedure for
self inspections (quality audit).
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20. STANDARD OPERATING PROCEDURES (SOPS)
• Standard operating procedures (SOPs) are the detailed written instructions that specify
how a test or administrative procedure is to be performed, or how a piece of equipment
is operated, maintained and calibrated.
• They indicate exactly how things are done, and are kept current by review and
approved revision on a predetermined schedule (usually annual), or when planned
changes are made to the procedure or equipment and reagents used in the procedure.
• The original of a current version of an SOPs is maintained in a central file, and copies
are distributed to the locations where the procedure is performed.
• The procedure for describing the writing, revising and approving of SOPs and the
control of distribution of SOPs is one of the important quality assurance procedures.
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21. • The term “change control” has recently been introduced to the vocabulary of pharmaceutical
manufacturing and control. Although this is primarily a term for validation procedures, it may also apply
to the control of the review and revision of SOPs for routine procedures.
• SOPs are used as a reference by the persons responsible for the performance, and are also used for
training new operators in the performance of the procedure. Quality assurance procedures should be in
place to ensure that SOPs are enforced and properly used.
• SOPs follow a scientific format, and are written with the view that they will be used by persons trained in
the procedure.
• They should be specific instructions for each step in sequential order including the preparatory work
which must be done before starting the main procedure, as well as instructions for recording and reporting
the results.
• Usually the initial draft of an SOP is written by the person performing the procedure or by someone who
knows the procedure well and must be written including the details and the time course of the tasks.
Supervisors review the SOPs for completeness and content and QC or QA staff approve for regulatory
compliance. 05-04-2022 21

22. • When appropriate, formal data sheet or data record form is prepared for an SOP. This form is a parallel
summary document with checklists, checkboxes, and blanks for all data to be recorded during the
performance of the procedure.
• It also has spaces for signatures of the operator and other technicians who verify and countersign certain
critical operations during the procedure.
• Finally, there is the space for the signature of the department supervisor who reviewed the completed data
record form.
• Blanks and checklists ensure that the required data are collected, that nothing is overlooked and also
provide the evidence that the procedure was performed according to the SOP.
• The datasheets also provide instructions for recording deviations to the procedure, for calculations or
reporting requirements, for comparison of results with predetermined specifications, and the criteria for
repeating procedures in cases where unacceptable results were obtained.
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23. Format for a standard operating procedure (SOP)
Name of facility ________________________________________________page .......... of ..........
SOP Number ________ Title _________________________________________________
Revision number ________
Written by ______________________________ Edited by __________________________
Authorization signature ________________________ Department _______ Date ___________
Effective date ____________________________________ Replaces ____________________
Purpose:
WHY:
Why is this procedure written.
Why is it being performed.
Scope
WHEN:
Indicate when this procedure needs to be performed.
WHERE:
Indicate where this procedure applies.
Responsibility
WHO:
Who performs the procedure, who is responsible to see it is performed correctly.
Materials and equipment
WHAT: What is needed to perform the test. The list should be complete and specific. 05-04-2022 23

24. SOP Number: .......... Rev...........Name of facility ........................................... page .......... of .......... Short title:
..................................................................................................
Procedure
HOW:
Clear concise, step by step instructions on how to perform the procedure. This should be written as instructions for the
operator to follow, without a lot of theoretical background. A section on fundamental principles can be included if
necessary.
It should include:
a) Preliminary steps that must be done before beginning the actual procedure.
b) Safety considerations: Precautions for work with physical, chemical, or biological hazards (containment facility
clothing, masks, hoods, goggles, gloves, clean up of spills etc.).
c) The chronological instructions. It is useful to number the steps so that repeat steps can be referred to rather than making
the SOP very long.
d) Calculations: Explanations and sample of how to do any required calculations.
Reporting
WHAT NEXT:
a) Indicate where the results should be recorded.
b) Explain what to do if there are problems during the test.
c) Indicate that deviations to the procedure must be approved and recorded.
d) Identify the person to whom the final results should be reported.
Reference documents:
List other SOPs which directly affect or are relevant to this procedure. For example, the SOP for making a buffer used in
the procedure, or the SOP for the operation of a piece of equipment used 05-04-2022
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25. MASTER FORMULA
• Master formula: A document or set of documents specifying the starting materials with their
quantities and the packaging, materials, together with a description of the procedures and
precautions required to produce a specified quantity of a finished product as well as the
processing instructions, including the in process controls.
• GMP documents from WHO and other countries all require that a Master Formula be prepared
and approved for each batch size of every product manufactured.
• The format for the MF should be a formal document with the company name, product name,
batch size, site of manufacture, a document number with revision number, and approval
signatures and dates. Each page should be numbered and spaces should be provided to fill in the
lot number of the batch and for approval signatures.
• The MF, and any revisions, must be approved, with dated signatures, by both Production and QA
officials.
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26. GMP CATEGORIES
• Sale
• Premises
• Equipment
• Personnel
• Sanitation
• Raw Material Testing
• Manufacturing Control
• Packaging Material Testing
• Finished Product Testing
• Quality Control Department
• Records
• Samples
• Stability
• Sterile Products
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27. GMP
• The Govt of India amended the drugs & cosmetics rules, 1945 on 24th june 1988 and prescribed GMPs
under Schedule M
• Schedule M has 2 parts, part 1 and part 2
• GMP guidelines come under part1
• The Schedule M has been revised and brought more less to the level of WHO GMP text
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28. WHO GMP ENSURES THE FOLLOWING:
• Avoidance of Cross- Contamination
• Prevention of Mix-ups
• Provide Traceability
• Accountability of actions
• Responsibility
• Product Performance Guarantee
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29. CONCLUSION
• From the above discussion we can conclude that
• Pharmaceutical Industry is regulated by GMPs
• Good Manufacturing Practices must be followed
• GMPs ensure drug products are safe, pure and effective.
• Good Manufacturing Practice is
Good Management Practice
Get More Profit
Give More Production
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30. REFERENCES
• https://www.nne.com/services/good-manufacturing-practice/
• https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/
• gmp-140930003330-phpapp02%20(1).pdf
• /goodmanufacturingpracticepritesh-160516130050.pdf
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