Certificate of Pharmaceutical Product (COPP) | What is COPP? | How to Apply for COPP? | Corpbiz скачать в хорошем качестве

Certificate of Pharmaceutical Product (COPP) | What is COPP? | How to Apply for COPP? | Corpbiz

We will be discussing the certificate of #pharmaceutical #products (COPP)…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 applies to a specific product, regardless of whether it is sold in the country of origin, and certifies that the drug's maker follows GMP and is routinely examined by national health authorities. The WHO-recommended format is used to create a COPP. The CPP for the pharmaceutical product, as well as a particular type of certificate that authorizes the registration and marketing of a certain pharmaceutical product in the exporting nation of interest, is required by the importing country and forms portions of the application for marketing authorization. When the medicine is intended for registration or renewal (license, authorization, or extension) by the importing nation for the scope of the product being sold or marketed in that country, the COPP is required. A certificate has been suggested to help small drug regulatory authority (DRA) or nations with insufficient quality assurance (QA) resources identify the quality of pharmaceutical goods by import or registration standards in WHO importing countries. This was the brief description of COPP now let’s move on to its objectives---A CoPP shows that imported medication meets the relevant standards of quality, safety, and efficacy to allow marketing, rigorous testing, and inspection by regulatory authorities in the exporting country and that it meets the relevant standards and procedures of Good Manufacturing Practice (GMP), which improves the product's quality and health. Drugs for which COPP may be issued • Approved drug products • Active Pharmaceutical Ingredients (API) • Over-the-counter (OTC) drug product • Unapproved product • Homeopathic drug So who can apply and what’s the procedure 1. The person/company that exports the product must present a complete application for export certification. 2. The qualification is intended for a drug that meets the criteria of the Act or the criteria of the Food Drug and Cosmetic Act. The process to obtain COPP certificate- Hard copy submission of application indicating fresh certificate of products applied • Application will be reviewed by the CDSCO officer and completed application in all aspects would be accepted for inspection on first come first serve • The forwarding letter/application shall be accompanied by a list of products applied for grant of COPP, along with the product permission copy and notarized product summary sheet, and site master file as per WHO GMP requirements. • List of major/master documents like master validation plan, quality manuals, specifications, master formula records maintained by the firm, and list of SOPs • List of personnel, list of equipment, instruments, utilities along with make and model and Capacity • List of primary and secondary impurity and reference standards/cultures available with the firm • Ate of 100 rupees in the form of DD is submitted along with the hardcopy of all other documents to the zonal CDSCO department. • In case of any query, a query letter will be issued to the applicant. Post-approval the applicant will receive a COPP certificate in hard copy form from CDSCO. So this was all about COPP certification for more such content subscribe to our channel Corpbiz. Know more: https://corpbiz.io​ Phone:- 7838392800 Email:- [email protected] Want to know more about #Corpbiz​? Subscribe to our Corpbiz channel to get the latest updates, tips, and help. https://bit.ly/3w7AFJ5 Website: https://corpbiz.io​ Facebook:   / corpbizhq​   Twitter:   / corpbizhq​   Instagram:   / corpbizhq   LinkedIn:   / corpbizhq