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What is COPPs? How to apply
for COPPs (Certificate of
Pharmaceutical Products)?
Pharmaceutical Business Blog
www.pharmafranchisehelp.com
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.
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
The certificate of pharmaceutical product (CPP or
CoPP) is a certificate issued in the format
recommended by the World Health Organization
(WHO).
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.
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.
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 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.
Documents required for applying for granting or
revalidation of COPPs:
Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
Documents required for applying for granting or
revalidation of COPPs:
1. Application from Manufacturer
2. Site Master file (as specified under WHO TRS 823)
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
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
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
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
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
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
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
Documents required for applying for granting or
revalidation of COPPs:
10.Manufacturing Layout Plan
Documents required for applying for granting or
revalidation of COPPs:
10.Manufacturing Layout Plan
11.Process validation for 3 batches of each product
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)
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
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
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
Hope above information is helpful to you...
Hope above information is helpful to you...
For any query and suggestion, mail us at
pharmafranchiseehelp@gmail.com

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What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?

  • 1. What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)? Pharmaceutical Business Blog www.pharmafranchisehelp.com
  • 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... For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com