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

What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)? – COPP (Certificate of Pharmaceutical Products) is one of the most important certificates for all pharma firms. Therefore if you are searching for some information regarding what is COPPs and How to apply for COPPs, Then you are at the right place. In this blog by Alpha Drugs, we will provide you some useful information regarding the same. Alpha Drugs has done its research and we have come up with some useful information for you folks. So first let us discuss what is COPP? COPP stands for Certificate of Pharmaceutical Products. This certificate is strictly recommended by the World Health Organization (WHO) and it is mandatory for the countries importing goods or medicines to submit this certificate. Apart from this, an application needs to be made as per requirements for the grant of WHO-GMP certificate, and one needs to submit this application to the respective subzonal or zonal officers.What is COPPs How to apply for COPPs (Certificate of Pharmaceutical Products)

 

According to the guidelines laid down by WHO and GMP, the zonal or the subzonal officer will issue the COPP certificate on behalf of the DGCI after getting clearance from CDSCO. From the date of issues, this certificate will be valid for 3 years and one can very easily reapply for renewal after the expiry of the mentioned period. So no as you are aware of what is COPP, below is some information related to How to apply for COPPs (Certificate of Pharmaceutical Products)?

For more information, you can get in touch with Alpha Drugs. Call us at +91-7988256670 or you can email us as well at Medfencelabs@gmail.com. 

Procedure to apply for COPPs (Certificate of Pharmaceutical Products)

Below are the steps that are mandatory to follow to acquire a COPP (Certificate of Pharmaceutical Products). These are:

  • As per the requirements, the application for the certificate of pharmaceutical products (COPP) needs to be made to the subzonal or the respective zonal. On behalf of the DCGI, the authorities will grant the certificate only after doing the entire inspection.
  • You have to submit a covering letter along with the detailed summary of all the products or medicines with the COPP application and this application must be made to the DDC or ADC of the zonal or subzonal officer.
  • It is necessary to mention the reason for the application. For what reason you are submitting it. Are you submitting it to acquire a brand new certificate or for renewal purposes. This point is crucial as the further process will be conducted accordingly.
  • You have to submit a detailed list of products, site master filer, list of goods, forwarding letter, and manufacturing license.
  • Quality manuals are mandatory to be submitted along with the COPP application combined with the entire master validation plan, specifications, manufacturing layout, and records.
  • A person must submit a detailed list of individuals combined with their work experience, education qualification, and designation. Apart from this, this is necessary to submit all the details regarding infrastructure like utilities, equipment list, and instruments.

Conclusion

Through this article, we try to enlighten the topic of what is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products and we hope that this blog was helpful and you got the information that you were looking for. Alpha Drugs has done its research and collected the above-mentioned useful information that is mentioned above. All the above-mentioned information is reliable and authentic. Moreover, this blog will give you a broad idea about COPP, the application process, and how to apply for COPP. But for more relevant information, check out our official website as rules and regulations keep on changing. If you carefully apply for a COPP certificate without committing a single error, then there is a good chance that you can acquire it on the very first attempt.

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Get in touch with us for more information. Give us a call at +91-7988256670 or you can email us as well at Medfencelabs@gmail.com.