The document discusses Certificate of Pharmaceutical Products (COPP), which is a certificate issued by the World Health Organization (WHO) that is required for pharmaceutical companies to export medicines globally. It regulates the import and export of drugs in India. To apply for a COPP, manufacturers must submit documents such as their manufacturing license, product lists, standard operating procedures, equipment lists, staff details and more to the relevant authorities. A COPP is valid for 3 years and helps ensure drugs meet quality standards before leaving the country.

1. What is COPPs? How to apply
for COPPs (Certificate of
Pharmaceutical Products)?
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2. The Central Drugs Standard Control Organization
(CDSCO), which is the national drugs regulatory
authority, regulates the import and export of the
drugs in the country, through the port offices located
in different parts of the country.

3. The WHO GMP certificate is mandatory in most
global markets for pharmaceutical companies to be
able to sell medicines. The manufacturer of an
exporting country must be licensed by the
regulatory authority of that country and comply with
the WHO GMP guidelines

4. The certificate of pharmaceutical product (CPP or
CoPP) is a certificate issued in the format
recommended by the World Health Organization
(WHO).

5. The certificate of pharmaceutical product (CPP or
CoPP) is a certificate issued in the format
recommended by the World Health Organization
(WHO).
The application for grant of WHO GMP Certificate of
Pharmaceutical Product shall be made to respective
zonal/sub zonal officers as per the requirement.

6. The COPP will be issued by Zonal/Sub Zonal officers
on behalf of Drugs Controller General (India) after
inspection and satisfactory clearance by CDSCO
officers as per WHO – GMP guidelines. It is valid for
3 years from date of issue and companies can apply
for renewal after that.

7. The certificate of a pharmaceutical product (COPP)
is issued under WHO GMP based on guidelines laid
down by the health agency and is aimed at
diminishing the risks inherent in pharmaceutical
production.

8. The certificate of a pharmaceutical product (COPP)
is issued under WHO GMP based on guidelines laid
down by the health agency and is aimed at
diminishing the risks inherent in pharmaceutical
production.
The certificate helps the regulator ensure that drugs
are consistently produced and are quality controlled
before they leave the country.

9. Documents required for applying for granting or
revalidation of COPPs:

10. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer

11. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)

12. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License

13. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License
4. List of Approved Products

14. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License
4. List of Approved Products
5. List of products applied for issuance of COPPs

15. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License
4. List of Approved Products
5. List of products applied for issuance of COPPs
6. List of SOPs and STPs

16. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License
4. List of Approved Products
5. List of products applied for issuance of COPPs
6. List of SOPs and STPs
7. Stability Data (3 batches) Accelerated / Real Time

17. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License
4. List of Approved Products
5. List of products applied for issuance of COPPs
6. List of SOPs and STPs
7. Stability Data (3 batches) Accelerated / Real Time
8. List of equipment and Instruments

18. Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
3. Copy of Manufacturing License
4. List of Approved Products
5. List of products applied for issuance of COPPs
6. List of SOPs and STPs
7. Stability Data (3 batches) Accelerated / Real Time
8. List of equipment and Instruments
9. List of Technical staff, their qualification, experience and approval
status

19. Documents required for applying for granting or
revalidation of COPPs:
10.Manufacturing Layout Plan

20. Documents required for applying for granting or
revalidation of COPPs:
10.Manufacturing Layout Plan
11.Process validation for 3 batches of each product

21. Documents required for applying for granting or
revalidation of COPPs:
10.Manufacturing Layout Plan
11.Process validation for 3 batches of each product
12.Schematic diagram of Water system specifying circulation loop and
MOC (Material of Construction)

22. Documents required for applying for granting or
revalidation of COPPs:
10. Manufacturing Layout Plan
11. Process validation for 3 batches of each product
12. Schematic diagram of Water system specifying circulation loop
and MOC (Material of Construction)
13. Schematic diagram of HVAC system specifying terminal filter
configuration

23. Documents required for applying for granting or
revalidation of COPPs:
10. Manufacturing Layout Plan
11. Process validation for 3 batches of each product
12. Schematic diagram of Water system specifying circulation loop
and MOC (Material of Construction)
13. Schematic diagram of HVAC system specifying terminal filter
configuration
14. Export data of last 2 years in case of revalidation

24. Documents required for applying for granting or
revalidation of COPPs:
10. Manufacturing Layout Plan
11. Process validation for 3 batches of each product
12. Schematic diagram of Water system specifying circulation loop
and MOC (Material of Construction)
13. Schematic diagram of HVAC system specifying terminal filter
configuration
14. Export data of last 2 years in case of revalidation
15.Product Summery sheet

25. Hope above information is helpful to you...

26. Hope above information is helpful to you...
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