COPP.pptx

Certificate of Pharmaceutical Product

1. CERTIFICATE OF PHARMACEUTICAL PRODUCT (COPP) VENUGOPAL N Assistant Professor Dept. of Pharmaceutics Sri Adichunchanagiri College of Pharmacy 1

2. What is a CPP? The National Health Authorities grant this CoPP certificate upon request from the consumer, the authorities, or the drug supplier in the importing country. This certificate refers to a particular product whether or not it is sold in the country of origin and also states that the manufacturer of the drug complies with GMP and that they are regularly inspected by the national health authorities 2

3. A CoPP is issued in the format which is recommended by WHO. It is the importing country which needs the CPP for the pharmaceutical product and a special type of certificate which allows the registration and marketing of a given pharmaceutical product in the exporting country of interest and forms sections of the application for marketing authorization. The CoPP is necessary when the drug is intended by the importing country for registration or renewal (licensing, authorization, or extension) for the scope of the product being sold or marketed in that country.

4. A certificate has been recommended to assist the undersized drug regulatory authorities (DRA) or also without sufficient quality assurance (QA) facilities in WHO importing countries and also to determine the quality of pharmaceutical products according to import or registration requirements. It is issued by the Inspectorate and the product supplier having GMP position and also the pharmaceutical, radiopharmaceutical, biological or veterinary drug status. The approved information is varied for various pharmaceutical formulations and strengths so it is often provided for a single product .

5. Objective of certification A CoPP demonstrates that imported medication is of the relevant standard of quality, safety and efficacy to allow marketing, rigorous testing and inspection in the exporting country to be carried out by regulatory authorities and shows that it meets the relevant standards and procedures of Good Manufacturing Practice (GMP) and improves the product's quality and health.

6. Importance of CoPP 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. To assess the quality of the product before registration or importation. 6

7. CPPs Commonly Issued Approved drug product Over the counter drug (OTC) product Unapproved drug product Homeopathic drug Drug in a bulk package (e.g. active pharmaceutical ingredient or API) To increase business in a foreign country it is necessary to obtain the COPP certificates by the pharmaceutical company 7

8. Who Can Apply The person/company that exports the product must present a complete application for export certification. The qualification is intended for a drug that meets the criteria of the Act or the criteria of the Food Drug and Cosmetic Act.

9. Submission A gency 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. 9

10. Format This certificate conforms to the format recommended by the World Health Organization No. of certificate Exporting (certifying country): Importing (requesting country): Name and dosage form of the product: 1.1. Active ingredient(s) and amount(s) per unit dose 1.2. Is this product licensed to be placed on the market for use in the exporting country?(yes/no) 1.3 Is this product actually on the market in the exporting country? If the answer to 1.2. is yes, continue with section 2A and omit section 2B. If the answer to 1.2 is no, omit section 2A and continue with section 2B: 10

11. 2.A.1. Number of product licence and date of issue: 2.A.2 . Product licence holder (name and address) 2.A.3 . Status of product licence holder: 2.A.3.1 . For categories b and c the name and address of the manufacturer producing the dosage form is: 2.A.4 . Is a summary basis for approval appended? (yes/no) 2.A.5 . Is the attached, officially approved product information complete and consonant with the licence ? (yes/no/not provided) 2.A.6 . Applicant for certificate, if different from licence holder (name and address): 11

12. 2.B.1. Applicant for certificate (name and address): 2.B.2 . Status of applicant:) 2.B.3 . Why is marketing authorization lacking? (not required/not requested/under consideration/refused) 2.B.4 . Remarks: 3 . Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced? (yes/no/not applicable ) If not or not applicable, proceed to question 4 12

13. 3.1. Periodicity of routine inspections (years) 3.2 . Has the manufacture of this type of dosage form been inspected? (yes/no) 3.3 Do the facilities and operations conform to GMP as recommended by the World Health Organization?(yes/no/not applicable ) 4 . Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product: (yes/no) If no, explain: Telephone : Fax : Name of authorized person : Signature: Address of certifying authority: Stamp and date  : 13

14. General requirements for submission of application for issue of COPP A forwarding letter/application shall be addressed to DDC(I)/ADC(I) of respective CDSCO zonal/sub zonal offices with copy of covering letter & product summary sheet to DCG(I) by authorized person only . Application should clearly indicate for fresh certification (Grant) or reissue of products applied, accordingly it will be scrutinized for the products applied. Applications will be reviewed by CDSCO officers and completed applications in all respects would be accepted for inspection on first come first serve basis. The forwarding letter/application shall be accompanied with List of products applied for grant of COPP, along with the a product permission copy (manufacturing license issued by the SLA) & notarized product summary sheet, site master file as per WHO-GMP requirement.  14

15. List of major/master documents like master validation plan, quality manuals, specifications, master formula records maintained by firm and list of SOP’s (to indicate the documentation system of firm). Manufacturing layout. List of personnel (with designation, qualification & experience), List of equipments , instruments, utilities along with make and model & capacity. List of primary & secondary Impurity and Reference standards/cultures available with the firm (relevant to the applied products for grant of COPP).  15

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17. Process CPP Application 17

18. Process Time CPPs are normally issued within twenty (20) government working days of application receipt Certification may not be issued Returned with a letter requesting additional information or missing information required in the CPP application Rejected : manufacturing facility status concerns (e.g. a violative facility inspectional status in FDA systems) Denied : drug is not in compliance with applicable regulation (e.g. misbranding not covered by an exemption) 18

19. Procedure for accepting the application for issue of COPP All applications received will be scrutinized by CDSCO Officials after receipt and query letter will be sent to applicant, if any or otherwise will be considered for inspection. Inspection will be carried out by CDSCO Officers as per WHO GMP guidelines of TRS 823/908 for non sterile products, TRS 822/902 for Sterile Products and other relevant guidelines in TRS937, TRS 929, TRS 863 etc. as applicable from time to time. 19

20. Self appraisal checklist should be filled and submitted to CDSCO officer before inspection. Inspection team verify the checklist at the time of inspection. Inspectors brief the inspection findings at the exit meeting. The report should clearly define deficiencies as per WHO GMP guidelines. Respective Zonal/ Sub‐Zonal certifying authority prepare “Review Report” based on review of observations of check list and written inspection report as per WHO GMP guidelines. 20

21. Firm may reapply, if required after proper compliance after 5months from date of rejection. If the same firm applies after 5 months, scrutiny of such application should be asked for earlier compliance with documentary evidences in addition to the usual general requirements for submission of application for issue of COPP. 21

22. Ribbons on CPPs Colored ribbons designate the type of CPP - Red for approved drug product, API, OTC marketed per monograph, and export only drugs. - Blue for unapproved drug product not marketed in the U.S. - Yellow for drug manufactured outside of the U.S. 22

23. Expiration of CPP CPP expires twenty four (24) months from the date issued A new CPP application must be submitted for all certifications 23

24. THANK YOU 24