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

The certificate of a pharmaceutical product is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and the applicant for this certificate in the exporting country. It is issued for a single product because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary. It is considered important because it is mandatory to submit it to the importing country when the product is intended for licensing authorization or renewal of registration. It is recommended by the WHO to facilitate the importing countries in assessing the quality of Pharma products. Also, it is a prerequisite for importation and registration.

Documents Required for applying for COPP Application

Here are some of the documents which you will require before applying for the certificate. Given below is the list of important documents to be attached with:

1. Application for: WHO-GMP certification & issuance of COPP.

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

3. Copy of Manufacturing License.

 4. List of approved products.

 5. List of products for which the firm has valid COPP.

 6. List of products applied for issuance of COPP & their composition.

 7. Site Master file (as specified under WHO TRS 823). 

8. Data on Finished Formulation: 

8.01 Master manufacturing formula, manufacturing process. 

8.02 Finished product specification and Method of Analysis.

 8.03 Stability study evaluation (Accelerated and Real-Time) for 3 batches including details batch size, Batch No., Date of manufacturing, Date of Expiry, stability study condition (Accelerated/ Real-time), Name of Drug, etc (as per Format-A)

 8.04 Process validation report for 3 batches.

 8.05 Validation report of the analytical method.

 9. List of technical staff, their qualifications, and experience and approval status. 

10. List of equipment and instrument.

 11. List of SOPs and STPs.

 12. Manufacturing Plant layout.

13. Schematic diagram of water system specifying the circulation loop and MOC. 

14. Schematic diagram of the HVAC system specifying terminal filter configuration.

 15. Export data of the last 2 years, in case of re-validation of COPP. 

16. Product summary sheet (as per Format B). 

17. Actual labels of the products applied for WHO-COPP. 

18. Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.

 19. Reference standards of the ingredients/formulation of the products applied for WHO-COPP 

20. Certificates of Analysis for three batches of each product 

21. Undertaking regarding the absence of any non-herbal ingredients including metals/ minerals, etc. in the products applied for WHO-COPPs. 

22. 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, etc.

Procedure for accepting the application

 The COPP will be issued by Zonal/ Sub Zonal Officers on behalf of drugs Controller General (India) after Inspection and satisfactory clearance by CDSCO (Central Drugs Standard Control Organization) officers as per WHO- GMP guidelines. It is Valid for 3 years from the date of issue and companies can apply for renewal after that. The certificate helps the regulator ensure that drugs are consistently produced and are quality controlled before they leave the country. 

All applications received will be scrutinized by CDSCO officials after receipt and a query letter will be sent to the applicant, if any or otherwise will be considered for inspection.

The inspection will be carried out by CDSCO officers as per WHO GMP guidelines of TRS 823/908 for nonsterile products, TRS 822/902 for sterile products and other relevant guidelines in TRS937, TRS929, and TRS863, etc. as an applicable time to time. The firm may reapply after 5 months from the date of rejection. 

Conclusion

Eridanus Healthcare is a certified pharmaceutical Company that Focused strongly on Innovation and Research, the company is present in more than forty-five therapeutic areas spread across all over PAN India. Eridanus Healthcare offers the products with high-profit margin plus, the quality of the products is high in standards. Here you will get all the ethical deals in the business.