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The certificate of 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.
1. It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
2. With the scope of commercialization or distribution in that country.
3. Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation.
The Certificate of Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. In the presence of such COPP, WHO recommends the national authorities to ensure that analytical methods can be confirmed by the national laboratory, to review and if necessary to adapt the product information as per local labeling requirements, and to assess bioequivalence and stability data. However, regulatory practices often vary in importing countries. Thus, in addition to CPP, assessment of application dossiers to support drug registrations, with different levels and complexity of requirements are considered necessary to satisfy full assurance on the appropriate quality of drugs.
WHO: The application for grant of WHO GMP Certificate of Pharmaceutical Product should be made to respective zonal/sub-zonal officers as per the requirement. The COPP should be issued by zonal/sub-zonal officers on behalf of the Drugs Controller General (India) after inspection and satisfactory clearance by CDSCO officers as per WHO-GMP guidelines.
General Requirements for Submission of Application for Issue of COPP
A forwarding letter/application should be addressed to DDC (I) / ADC (I) of respective CDSCO zonal/sub-zonal offices with a copy of the covering letter and product summary sheet to DCG (I) by authorized person only.
1. Application should indicate for fresh certification (Grant) or reissue of products applied, accordingly, it will be scrutinized for the products applied.
2. Applications should be reviewed by CDSCO officers and completed applications in all respects should be accepted for inspection on a first come first serve basis.
3. The forwarding letter/application shall be accompanied by a list of products applied for grant of COPP, along with a product permission copy (manufacturing license issued by the SLA) and notarized product summary sheet, site master file as per WHO-GMP requirement.
List of major/master documents like master validation plan, quality manuals, specifications, master formula records maintained by the firm, and list of SOPs (to indicate the documentation system of firm).
1. List of personnel (with designation, qualification, and experience), List of equipments, instruments, utilities along with make and model and capacity.
2. List of primary and secondary impurity and reference standards/cultures available with the firm (relevant to the applied products for grant of COPP).
Procedure for Accepting the Application for Issue of COPP
The certificate of pharmaceutical product has been issued under WHO-GMP based on guidelines laid down by health agency and also aimed at diminishing the risk inherent in pharmaceutical productions. The certificate helps the regulator to ensure that drugs are consistently produced and are quality controlled before they leave the country.
Documents Required for Applying for Grating or Revalidation of Copps:
1. Application from the manufacturer.
2. Site master file (as specified under WHO TRS 823).
3. Cost 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 equipments and instruments.
9. List of technical staff, their qualification, and experience, and approval status.
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 the last 2 years in case of revalidation.
15. Product money sheet.
Timeline and Fees for NDA
It generally takes about one year to secretaries these documents by technical data associates/Drug inspector of CDSCO during the period clarification if any, are required by them are answered and thereafter the imported gets the approved TR Challan of 50000 rupees is required for fresh application’s Challan of 15000 rupees is required subsequent application.
1. Documents to be submitted by an Indian agent.
2. Form 40: It should be signed and stamped by an Indian agent.
3. Documents to be submitted by the manufacturer.
4. POA: Power of attorney should be consulate from the Indian embassy of the other country of origin, and should be co-jointly signed by both the parties i.e. manufacturer and Indian agent.
Schedule DI and DII:
They should be signed and stamped by the manufacturer (Need not be notarized).
1. Notarized plant registration certificate.
2. Notarized manufacturing and marketing license
3. Notarized free sale certificate
4. GMP/COPP certificate notarized.
(A)Plant master file: It should include the following points:
- Sketch of the plant.
- Profile of the company.
- Organogram of the company.
- Plant and machinery.
- Hygienic and sanitary measure details.
- HVAC system.
- Men’s material movement.
(B) Drug master file: It should include the following points:
- Manufacturing process/flow chart.
- Quality assurance procedures/process controls.
- The provision to control contamination and cross-contamination in the final product.
- Process control, control of critical steps, and intermediates.
- Container closure system.
- Risk Assessment as per ISO 14971.
- Process validation/verification.
- Stability data.
- Biocompatibility and toxicological data.
- Clinical studies and reports.
Postmarketing Surveillance: It is the part of the Device Master File, and it should include the following points:
- Procedures for distribution of records.
- Complaint handling.
- Adverse incident reporting.
- Procedure for product recall.
- Corrective action was taken.
(C) Labels and Inserts:
Product labels should show the address of the manufacturer. Product inserts should describe a brief description of the product and its intended use.
Processing Procedure: After ensuring all documents correctly as per the requirements of FDA, it generally takes about 2-3 months to scrutinize these documents by Technical Data Associates/Drug inspectors of CDSCO, and during this period, clarifications if any, required by them are answered and thereafter we get the Registration Certificate (RC) in Form 41.
Import Processing: After getting the registration certificate from CDSCO, the Indian agent is to import the products from the manufacturer. Following documents are further required to get Form 10 (Import license).
Form 8: TR Challan – (1000 rupees for 1st product than 100 rupees for each additional product).
- Copy of Wholesale License (Indian agent)-Notarized.
- Copy of Registration Certificate-Notarized.
TimeLine For Import License: The Importer (Indian agent) is not authorized to import the products from a foreign manufacturer unless he obtains an Import license (Form 10) from CDSCO. It generally takes about one month to scrutinize these documents by Technical Data Associates/Drug inspectors of CDSCO and during this period, clarifications if any, required by them, are answered after that the importer gets the Import license. For Import license application TR Challan of 1000 rupees for 1st product then 100 rupees for each additional product is required.
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