LIST OF DOCUMENTS REQUIRED FOR APPLICATION FOR WHO-GMP/ CoPP

FOR A.S.U. HERBAL DRUGS

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. Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
19. List of Reference standards/ marker for all active ingredients / formulation of the
products applied for WHO-CoPP
20. Certificates of Analysis for three batches of each product
21. Undertaking regarding absence of any non-herbal ingredients including metals/
minerals, etc. in the products applied for WHO-CoPPs.
22. 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.

1
 #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 12month 18 24month 36 48 60
month month month month month

01

02

# Format-B : Product summary sheet

Sr
Not
period

Cleaning

method
Name of Products (along with

No of batches manufactured in

Availability of Reference &

scale

Mfg Lic / Product permission

(Completed/ Not Completed)

Not Completed)

No
up/R&D/Pilot/Commercial)

(Completed/

Annual product review

(with

validation/Verification
of Analytical
Stability Data

Working Standard
Process Validation
(Maximum

COPP issue date

completed)
its composition)

of
2years

(Completed/

Completed)
validation
Status

Status

Accele Real
last

rated Time
01

02