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

COPP refers to the Certificate of Pharmaceutical Products that is the WHO recommended certificate. The format is made in accordance with WHO guidelines and it is uniform across the globe. It is considered essential because it is mandatory to submit it to the importing country when the product is intended for licensing authorization or renewal of registration. This certificate is valid for 3 years from the date of issue and companies can apply for renewal after that.

DM Pharma is one of the leading pharma companies in India. The company is committed to providing the best PCD pharma franchise services and quality products in every nook of the nation. In this blog post, we are here to provide you information about What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?

What are the Documents Required for Applying for Granting COPPs?

• An application from the manufacturer
• Site Master File
• List of STPs and SOPs 
• Stability Data
• List of instruments and equipments
• Manufacturing license copy 
• Manufacturing layout plan
• List of Technical staff, experience, their qualification and approval status
• Process validation for 3 batches of every product.
• Schematic diagram of HVAC system stating terminal filter configuration
• Schematic diagram of water system specifying circulation MOC and loop. 
• Summary sheet of product
• Approved products list 

Process of COPs Application 

• According to the necessity, the application for COPP must be made to the zonal or sub-zonal officials. When the specialists perform investigation and give agreeable freedom, they issue the testament in the interest of Drug Controller General India. 
• The application must be routed to DDC or ADC of the zonal or subzonal officials. A covering letter and item rundown ought to be submitted alongside the letter. 
• It must be obviously referenced that whether the application is for new confirmation or reissue? The examination procedure will happen likewise. The CDSCP official surveys the application and acknowledges it in the event that it is discovered alright. 
• Alongside the sending letter, you ought to present the rundown of items, item fabricating permit, item outline sheet, and site ace document. 
• Present the quality manuals alongside details, ace approval plan, ace recipe records, and assembling design with the application. 
• You have to give the rundown of individuals with their capability, assignment, and experience. Foundation subtleties, for example, a rundown of hardware, utilities, and instruments are required.

What is the Procedure for Accepting the Application? 

CDSCO officials check and examine the application. They should investigate according to WHO rules.

The agenda is checked during the assessment. The report makes reference to inconsistencies assuming any. Zonal and sub-zonal specialists make a survey report and examination report as indicated by the rules.

Whenever dismissed, at that point the firm needs to reapply after consistency following 5 months. Prior consistence reports must be submitted with that.

The blog gives an expansive thought of the application procedure, different stages engaged with it, and the way toward tolerating an application.

Be that as it may, it is in every case better to check the official sites for pertinent data. Since the principles, standards, and methods are liable to transform, it is in every case better to get refreshed data.

In the event that there is no blunder in applying, at that point there is a reasonable possibility of getting it through in one endeavor.

Conclusion 

We hope that got all the necessary details regarding the COPs certificate. In the pharma sector, it is very important as it is laid down by WHO-GMP. Well if you are searching for the right and trusted PCD franchise company then DM Pharma can be your ideal choice.