Good manufacturing practice (GMP) is a system whereby it is ensured that the products are consistently produced and controlled according to quality standards as prescribed in line with the WHO. The intent behind such certification is to minimize the risks involved in any pharmaceutical production.

COPP: Certificate of a Pharmaceutical Product (COPP)

The COPP is the legal document that certifies that the manufacturing company having this certificate is legally allowed to sell their pharmaceutical product in the country they are producing.

Following Documents Are Required For Making An Application For GMP Certification & Issuance Of COPP

1. Name, address, telephone, fax, e-mail etc of the applicant

2. Copy of Manufacturing Licence (In case of loan licence or third party)

3. List of products their composition (For which COPP is availed and otherwise).

4. Master Plan of the site.

5. Master manufacturing formula along with the process of manufacturing.

6. Method of Analysis

7. Specification of the Final product.

8. Reports Required:

> Batch Wise Evaluation of stability, (should include the Date of manufacturing, Date of Expiry, stability study condition, Name of the drug etc)

> Process validation report of 3 batches for Herbal Products.

> Validation report of the analytical method.

9. Certificates of Analysis for three batches of each product. (Applicable in case of herbal products), (Applicable in case of herbal products).

10. List comprising of details of technical staff.

11. List of machinery, equipment and instruments (Used and to be used).

12. Layout of the Manufacturing Unit.

13. Water system diagram.

14. HVAC system diagram.

15. Export data for the last 2 years (wherever re-validation of COPP is applicable)

16. Final labels (which are to be printed) required for which WHO-COPP is to be obtained.

17. Proof of Safety and effectiveness as per the Rule 158B of Drugs & Cosmetic Rules, 1945.

18. Undertaking regarding the absence of any non-herbal such as metals/ or minerals, etc. in the products applied for WHO-COPPs i.e Applicable in case of herbal products.

19. Undertaking regarding compliance with the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder, (Applicable in case of herbal products).