List of Documents required for application for WHO-GMP/CoPP for Ayurvedic, Siddha and Unani Herbal Drug
For exporting Ayurvedic, Siddha and Unani medicines, importing country ask for CoPP for registration of product in its country. CoPP will be issued by Drug Control Cell, Ministry of AYUSH.
Important Links:
List of Documents:
1. Application for: WHO-GMP certification & issuance of COPP.
2. Name of the applicant with address, telephone, fax, e-mail etc.
3. Copy of Manufacturing Licence.
4. List of approved products.
5. List of products for which the firm has valid CoPP. (Applicable for revalidation of CoPP)
6. List of products applied for issuance of COPP & their composition.
7. Site Master file (as specified under WHO TRS 823).
8. Data on Finished Formulation:
8.01 Master manufacturing formula, manufacturing process.
8.02 Finished product specification and Method of Analysis.
8.03 Stability study evaluation (Accelerated and Real Time) for 3 batches including details batch size, Batch No., Date of manufacturing, Date of Expiry, stability study condition (Accelerated/ Real time), Name of Drug etc (as per Format-A) (Minimum 06 months period for Accelerated Stability data and 12 months for Real time Stability data shall be submitted at the time of initial application.)
8.04. Process validation report for 3 batches
8.05 Validation report of analytical method.
9. List of technical staff, their qualification, and experience and approval status.
10. List of equipment and instrument.
11. List of SOPs and STPs.
12. Manufacturing Plant layout.
13. Schematic diagram of water system specifying circulation loop and MOC.
14. Schematic diagram of HVAC system specifying terminal filter configuration.
15. Export data of last 2 years, in case of re-validation of CoPP.
16. Product summary sheet (as per Format B).
17. Actual labels of the products applied for WHO-CoPP.
18. List of Reference standards/ marker for all active ingredients / formulation of the products applied for WHO-CoPP
19. Certificates of Analysis for three batches of each product
20. Undertaking regarding absence of any non-herbal ingredients including metals/ minerals, etc. in the products applied for WHO-CoPPs.
21. Undertaking regarding compliance to the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder, etc.
Note: The application for grant/ renewal of WHO-GMP/ CoPP along with all the supporting documents as per the check list is to be addressed to the Office of DCG(I), CDSCO(HQ), New Delhi and simultaneously to the Drug Control Cell, Ministry of AYUSH.
Hope above information is helpful to you....
2. Name of the applicant with address, telephone, fax, e-mail etc.
3. Copy of Manufacturing Licence.
4. List of approved products.
5. List of products for which the firm has valid CoPP. (Applicable for revalidation of CoPP)
6. List of products applied for issuance of COPP & their composition.
7. Site Master file (as specified under WHO TRS 823).
8. Data on Finished Formulation:
8.01 Master manufacturing formula, manufacturing process.
8.02 Finished product specification and Method of Analysis.
8.03 Stability study evaluation (Accelerated and Real Time) for 3 batches including details batch size, Batch No., Date of manufacturing, Date of Expiry, stability study condition (Accelerated/ Real time), Name of Drug etc (as per Format-A) (Minimum 06 months period for Accelerated Stability data and 12 months for Real time Stability data shall be submitted at the time of initial application.)
8.04. Process validation report for 3 batches
8.05 Validation report of analytical method.
9. List of technical staff, their qualification, and experience and approval status.
10. List of equipment and instrument.
11. List of SOPs and STPs.
12. Manufacturing Plant layout.
13. Schematic diagram of water system specifying circulation loop and MOC.
14. Schematic diagram of HVAC system specifying terminal filter configuration.
15. Export data of last 2 years, in case of re-validation of CoPP.
16. Product summary sheet (as per Format B).
17. Actual labels of the products applied for WHO-CoPP.
18. List of Reference standards/ marker for all active ingredients / formulation of the products applied for WHO-CoPP
19. Certificates of Analysis for three batches of each product
20. Undertaking regarding absence of any non-herbal ingredients including metals/ minerals, etc. in the products applied for WHO-CoPPs.
21. Undertaking regarding compliance to the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder, etc.
Note: The application for grant/ renewal of WHO-GMP/ CoPP along with all the supporting documents as per the check list is to be addressed to the Office of DCG(I), CDSCO(HQ), New Delhi and simultaneously to the Drug Control Cell, Ministry of AYUSH.
#Format-A : Stability Study Data
Name of
the Product: Batch No: Batch
Size: Manufacture Date: 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
|
|
|
|
|
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02
|
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# Format-B :
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 Analytical method validation (Completed/ Not
|
Availability of Reference
& Working Standard
|
Annual
product review
|
Mfg
Lic / Product permission
|
COPP
issue date
|
|
|
Accele
rated
|
Real
Time
|
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01
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02
|
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Hope above information is helpful to you....
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com
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