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

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

COPPs or Certificate of Pharmaceutical Products is the WHO recommended certificate which is compulsory for all the pharma companies in India as well as across the world. The format is made as per WHO guidelines and important for the entrance in the pharma industry. This certification is important to submit when there is an intended for licensing authorization or renewal of registration. So, if you are planning to start PCD Pharma Franchise Business we at Amzor Healthcare will help you out for guidance towards the right path with all useful information and requirements details.

Why COPPS in Pharmaceutical Industry is Important? 

The certification of COOPs is recommended by WHO to facilitate the importing countries in assessing the quality of pharma products. The Central Drugs Standard Control Organization (CDSCO), which is the national drug regulatory authority, regulates the import and export of the drugs in the country, through the port offices located in different parts of the country.

• It is highly recommended by the World Health Organization (WHO).
• It is processed in 20 government working days.
• The sign for the product that is distributed or commercialized in that country.
• Regulatory practices vary in importing countries.

The list of types of Medicines which COPP Issue in Country

There are different types of medicines which require the COPPS Certification in all over the countries. The request is made to the exporting country’s health authority by the Marketing Authorization Holder (MAH). Here are the mentioned medicines list which requires a compulsory COPPS Certificate. 

•  Homeopathic Medicines
•  OTC products
•  Active pharmaceutical ingredients
•  Approved drugs

The process and procedure for COPPs Application in India- Amzor Healthcare

The COPPs are mandatory in many countries that require a World Health Organisation (WHO) accreditation for pharmaceutical products being imported. If you are willing to apply for COPPs certification we at Azmor Healthcare have enlisted the procedure for COPPs application as follows.

1. The prior task of being a COOPs certification it has to be made to zonal or sub-zonal officer.
2. Authorities after inspection give satisfactory clearance (Issues on the behalf of Drug Controller General India).
3. After DCGI application has to be addressed to DDC or ADC of the zonal or sub-zonal officer.
4. It includes the cover letter which has a product summary. (Mandatory to submit along).
5. The CDSCP officer reviews the application and chooses whether it needs to be accept or reject.
6. When the transmit letter is submitted it is important to check and submit the list of products, product manufacturing licenses, and product summary sheets as well.
7.  The list of employees with detailed qualification, designation, and experience must be submitted.
8. Details regarding equipment, utilities, and instruments must be submitted.
9. The quality manuals are also required along with specifications, master validation plans, and manufacturing layout application.

We at Amzor Healthcare is one of the leading companies for PCD Pharma Franchise in India. If you are planning to expand or start a new franchise business contact us once we are always there to assist you. We have a wide range of products are affordable rates. Our company is a well-renowned brand in the pharma industry for years and known for the best products and service quality. For more information and details contact us 24x7 we are always there for delivering the 100% customer satisfaction with our top-class services.