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

The CoPP is mandatory in many countries that require World Health Organisation (WHO) accreditation for pharma products being imported. As laid down by the WHO, the GMP certification is also necessary for the same. Every pharma related activities like import and export controlled by Government authorities. For every work there is a department like the CDSCO controls the drug segment. There are certain laws for carrying out medicine activities in the market and to take the authorization PCD Pharma Franchise companies have to complete all legal formalities. Without completing selling medicines in the market is illegal. It is valid for 3 years from date of issue and companies can apply for renewal after that.

Why it is important to get COPP?

COPP is an important document as it claims that the imported medicine is of the appropriate standard of quality and the safety in the use of the products. If we are running our business in PCD Pharma Franchise and looking for expansion in abroad countries then, it is necessary to obtain the CoPP certificate.

Document required for applying for granting or revalidation of COPPs:

•             Application from Pharma manufacturer

•             Site Master File (as per WHO TRS 823)

•             Copy of Production License

•             List of medicines applied for insurance of COPPs

•             List of Approved medicines

•             List of SOPs and STPs

•             Stability Data Accelerated / Real Time.

•             List of equipment’s, machines and other instruments

•             Information of  technical Staff, their qualification, experience and approval status

•             Manufacturing Layout plan (Blue Print)

•             Process validation for 3 batches of every medicine

•             Schematic diagram of HVAC system

•             Export data of Last 2 year in case of revalidation

•             Product Summary Sheet

The Process of CoPP Application

·         The DDC OR ADC of the Zone or sub-zonal officer has to be addressed in the application. Product summary and a covering letter have to be submitted along with the letter.

·         The plaintiff must clearly state whether the appeal is fresh or is a case of re-issue. Accordingly, the scrutiny will take place. If the application is found ok then it is accepted by the CDSCP officer.

·         The list of medicines, product manufacturing license, summary sheet, site master needs to be submitted along with the forwarding letter.

·         Along with the specifications, master validation plan, master formula records and production layout, quality manuals are to be submitted with the application.

·         Details of employees with their qualification, designation, experience and infrastructure details are also required to be submitted.

·         The application has to be made to zonal or sub-zonal officer. They will issue the certificate on behalf of Drug Controller General India. Once the inspection is done and clearance is given, then the certificate is issued by the company.

Companies like Sanify Healthcare is the top company which work as per rules and regulations. The company is known for its finest quality medicines. For selling it in  the market the company offers monopoly rights based PCD Pharma Franchise deals. So associating with them is good for franchise business.

Conclusion

This is not just a piece of paper. It is an important certification which is required for every reliable pharma company for enter world pharma market. Certifications helps to get good image in the market.