The Central Drugs Standard Control Organization (CDSCO), which is the national drugs regulatory authority, regulates the import and export of the drugs in the country, through the port offices located in different parts of the country.
The WHO GMP certificate is mandatory in most global markets for pharmaceutical companies to be able to sell medicines. The manufacturer of an exporting country must be licensed by the regulatory authority of that country and comply with the WHO GMP guidelines
The certificate of pharmaceutical product (CPP or CoPP) is a certificate issued in the format recommended by the World Health Organization (WHO). The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers as per the requirement. The COPP will be issued by zonal/sub zonal officers on behalf of Drugs Controller General (India) after inspection and satisfactory clearance by CDSCO officers as per WHO – GMP guidelines. It is valid for 3 years from date of issue and companies can apply for renewal after that.
Important Links:
- How to export medicines from India?
- Pharmaceutical Manufacturing License Number
- Pharmaceutical Marketing Company license
- Goods and Service Tax Identification Number
- Importer Exporter Code (IEC) Number
The certificate of a pharmaceutical product (COPP) is issued under WHO GMP based on guidelines laid down by the health agency and is aimed at diminishing the risks inherent in pharmaceutical production. The certificate helps the regulator ensure that drugs are consistently produced and are quality controlled before they leave the country.
Documents required for applying for granting or revalidation of COPPs:
- Application from Manufacturer
- Site Master file (as specified under WHO TRS 823)
- Copy of Manufacturing License
- List of Approved Products
- List of products applied for issuance of COPPs
- List of SOPs and STPs
- Stability Data (3 batches) Accelerated / Real Time
- List of equipment and Instruments
- List of Technical staff, their qualification, experience and approval status
- Manufacturing Layout Plan
- Process validation for 3 batches of each product
- Schematic diagram of Water system specifying circulation loop and MOC (Material of Construction)
- Schematic diagram of HVAC system specifying terminal filter configuration
- Export data of last 2 years in case of revalidation
- Product Summery sheet
#Format : Stability Study Data
Name of the Product: Batch No: Batch Size: ManufactureDate: Study Initiation Date: Storage Condition: Pack style:
Accelerated Study: Time Points (Month)
| Test | Specification | Initial | 3 month | 6month |
| 01 | ||||
| 02 |
Real Time Study: Time Points (Month)
Sufficient to establish the Stability profile of the drug
| Test | Specification | Initial | 6 Month | 12 Month | 18 Month | 24 Month | 36 Month | 48 Month | 60 Month |
| 01 | |||||||||
| 02 |
# Format : Product summary sheet
| Sr. No. | Name of Products (along with its composition) | No of batches manufactured in Last 2years (with scale) | Stability Data (Maximum period completed | Process Validation (Completed/ Not Completed) | Status of Cleaning validation/Verification | Status of Analyticalmethod validation (Completed/ Not | Availability of Reference & Working Standard | Annual product review | Mfg Lic / Product permission | COPP issue date | |
| Accerated | Real time | ||||||||||
| 1 | |||||||||||
| 2 |
Hope above information is helpful to you….
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