Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke https://youtube.com/vishalshelke99 https://instagram.com/vishal_stagram Sub :- Drug Regulatory Affairs M.Pharm Sem II Savitribai Phule Pune University

1. Presented By :- Mr. Vishal D Shelke.
M.Pharm Sem – II
Guided By :- Dr. S.J. Pawar.
Department of Pharmaceutics

2.  Introduction to GMP
 Principle of GMP
 WHO GMP Certification
 Certificates
 Conditions for Scheme
 Inspection
 Indian GMP Certification
 References

3. What is GMP?
Good manufacturing practice (GMP) is a system for ensuring that
products are consistently produced and controlled according to
quality standards. It is designed to minimize the risks involved in
any pharmaceutical production that cannot be eliminated through
testing the final product.
A GMP is an important enhancement to your food safety
management system, which increases your customers’ confidence in
your commitment to trading and producing safe, high quality food.

4. Principles of GMP
The 10 Principles of GMP are :
• Design and Construct the facilities and equipments properly.
• Follow written procedures and Instruction.
• Document work.
• Validate work.
• Monitor facilities and equipment.
• Write step by step operating procedures and work on instructions.
• Design, develop and demonstrate job competence.
• Protect against contamination.
• Control components and product related processes.
• Conduct planned and periodic audits.

5. Documents need for GMP Certification :-
The key sections of GMP set out a range of documents
requirements for
minimize the risks involved in any pharmaceutical production that
cannot be eliminated through testing the final product.
• GMP Manual
• GMP Procedures
• GMP Process Approach
• Standard Operating Procedures (SOPs)
• Exhibits
• Sample Formats / Templates
• GMP Audit Checklist

6. It was Originally promugulated in 1969 and revised in 1975.
Main objectives were :
 Guidelines be developed for official inspections of dug
manufacturing facilities
 To assess compliance of GMP
With 191 countries members in the scheme a solution was
found for international commerce between these countries. The
scheme offered a solution for those countries which did not
have a developed regulatory agency yet wanted to import drugs.

7. Basic principles of WHO Good Manufacturing Practice is
similar to any established GMP requirement. Allied
documents like Schedule M, CFRs, ASEAN GMP, etc are
all similar in nature. Anyone following any established
GMP procedure will automatically understand the
principles in the other GMP requirements.
WHO GMP requirements have been developed taking into
account the principles in various GMP texts and also
considering the requirements of developing countries.
These requirements are not for domestic use but for
international trade.

8. There are around 1000 (?) WHO GMP certified manufacturing
establishments in the country, with West Zone leading followed by
the South, North and the East Zones.
New Applications are coming in everyday due to increase in
exports of drugs, India being a major exporter of Drugs &
Pharmaceuticals Globally.
Other purchasers like the State governments, ESI etc. have also
started (erroneously) asking for the certificates as preconditions.
WHO GMP ensures the following :
 Avoidance of Cross- Contamination
 Prevention of Mix-ups
 Provide Traceability
 Accountability of actions
 Responsibility
 Product Performance Guarantee

9. Certificates
Three types of certificates are recommended by the WHO.
These are:
1) Product Certificate (COPP) (TRS 823, 863)
2) Statement of Licensing Status (TRS 823, 863)
3) Batch Certificate (TRS 823, 863)

10. The member state shall attest the following conditions of a
manufacturer if required to attest a product for the
certification:
1. A specific product is authorized to be placed in the
market of the exporting country, if not why not
2. The manufacturing plant is subject to regular
inspections for WHO GMP compliance
3. All product information, including labeling is currently
authorized in the certifying country.

11. Conditions to be satisfied before opting for the scheme
by any member country
Effective national licensing system for products, manufacturers
and distributor
Effective control of quality of products, including independent
laboratory
A technically competent, experienced, resourceful National
Pharmaceutical inspectorate, as part of NDRA having legal powers
for investigations
Administrative capacity to issue Certificates and quickly notify
WHO and other member countries

12. PART I
Quality Management in the Drug Industry –
Philosophy & Essential Elements
 Quality Assurance
 Good Manufacturing Practice
 Quality Control
 Sanitation & Hygiene
 Validation
 Complaints

13. PART II :
Good Practices – Production & Quality Control
 Good Practices in Production
 Includes General requirements, prevention of cross contamination
and bacterial contamination, processing operations, packaging
operations
 Good Practices in Quality Control
 Control of starting material and intermediate, bulk, and finished
products, test requirements, production record review, stability
studies

14. PART III:
Supporting and Supplementary Guidelines
Sterile pharmaceutical Products
General requirements (air classifications), manufacture of sterile
preps, personnel, premises, equipment, sanitation, processing,
sterilization, filtration, finishing, quality control,
Good Manufacturing Practice for Active Pharmaceutical
Ingredients
Explanation, general considerations, personnel, premises,
equipment, sanitation, documentation, retention of records and ref
samples, production.
Form and content of inspector’s report
Validation of analytical procedures

15. One of the most important TRS
Supplementary guidelines on GMP for HVAC
(Supplementary guidelines on GMP for Herbals)
Supplementary guidelines on GMP : Validation
 HVAC Water Systems
 Cleaning
 Analytical Method
 Computerized Systems
 Qualification of systems and equipment
 Non-sterile process validation
 Good Distribution Practices for pharmaceutical
products

16. How to Certify a Product
 Certification of products are done after thorough
examination of the product and the facilities where
these are manufactured The facilities are Inspected
NRA Inspectors with good knowledge of GMP
 The inspection may take two or more days
 Certificates are issued by the Issuing Authority on
the recommendation of the joint report

17. Requirements
Procedures Main Requirements
A. Product
B. Procedures
C. Facilities
A. Product
The basic requirements of the product are:
1. Product design
2. Stability Studies
3. Process validation

18. B. Procedures
All actions taken in the facility which leads to the
production of the final product as per
specification.
C. Facilities
This encompasses the building, machinery, services
and utilities, manpower etc. These are guided towards
making a properly designed product.

19. Inspection Points
1. Quality Management
2. Sanitation and hygiene
3. Validation
4. Complaints and recalls
5. Contract production and analysis
6. Self Inspection
7. Personnel
8. Premises
9. Equipment
10. Materials
11. Documentation
12. Sterile production
13. Active pharmaceutical ingredients

20. GMP consists of various activities which an be grouped
together as follows:
1. Training - induction, ongoing, refresher etc.alonwith such
documents like SOP, training calendar, assessment etc.
2. Cleaning sanitation and hygiene - may also include
workers entry procedure, cleaning of the
premises etc
3. Validation and calibration - qualification of machinery,
equipment etc.
4. Storage - apart from normal ware-housing facilities, this
should also address quarantine, procedure Etc.

21. 5. movement of manpower, material –
uni-flow movement, movements control etc.
5. Quality assurance –
6. Quality control
5. Documentation –
must include MFR, BPR, SOP Documents control &
distribution, cleaning, training, and document regulating and
recording other activities
5. Change control –
6. Self inspections and audits

22. GMP Inspections in India
FDA conducts facility inspections for products to be sold in the
US
Doesn’t include CTM facilities
Doesn’t include clinical stage products
About 100 Indian facilities have been inspected by the FDA
Otherwise India relies on local inspectors

23. Pharma companies in India don’t pay taxes for their first
ten years
Over 20,000 pharma companies in India
They don’t go through complex certification procedures
FDA only conducts facility inspections for products to
be sold in the US

24. GMP Regulations in India
Up to 1970, Schedule M of India’s Drug &Cosmetics Act was
in place
Advent of GMP requirements covered the gaps
Regulations were harmful to the small players
Consolidation of Schedule M and GMP put onhold until 2005
Amendment of Schedule M is more lenient
Small and medium size enterprises are still in the process of
adopting GMPs

25. 1) Good Design Practices for GMP Pharmaceutical
Facilities “Andrew A. Signore, Terry Jacobs” Page No
:- 180 – 200
2) Good Manufacturing Practices for Pharmaceuticals
Second Edition “Sidney H. Willig. Murray M.
Tuckerman. William S. Hitchings Page No – 150-175
3)https://slideshare.net
4)https://pharmapathway.com
5)http://www.health.gov.au/tga/docs/html/gmphome.html
6)https://mca.gov.uk

26. Also available on Youtube!
Youtube :- https://youtube.com/vishalshelke99
Instagram :- https://instagram.com/vishal_stagram

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