CDSCO updates procedure for issuance of WHO GMP
New Delhi: Through a recent notice Central Drugs Standard Control Organization (CDSC0), Directorate General of Health Services, has laid down procedures for the inspectorate in India for issuance of WHO-GMP (CoPP) and to reduce the number of inspections for the same manufacturing sites for various reasons
The confirmation of the same was made by Dr V G Somani, Drugs Controller General (India) (DCGI) to communication to All Zonal, Sub-Zonal offices of CDSCO to co-ordinate with respective states/UTs .
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
In its circular, the DCGI noted that in order to streamline the process of issuance of WHO-GMP (CoPP) through a uniform procedure of review and joint inspection, a detailed deliberation was made in the 47th DCC held on 30-31 July 2014 and guidance of joint inspection was minuted under Agenda 12.
In accordance with the guidance laid down in the 47th DCC and to reduce the number of inspections for the same manufacturing sites for various reasons by officers of CDSCO zonal, sub-zonal and State Licensing Authorities (SLAB), it has been decided to adopt following procedures for the inspectorate in India with a primary focus towards quality compliance to product and manufacturing process:
For issuance of CoPP for the purpose of grant/revalidation/ or issuance of additional product :
A. - The applicant shall submit the application along with supporting document & details given in checklist (Annexure A) & Product Summary Sheet (Annexure B), as per the guidance in the 47th DCC minutes
a. Application from Manufacture
b. Site master file (as specified under WHO TRS 961, Annexure 14)
c. Copy of Manufacturing license.
d. List of Approved Products.
e. List of products applied for issuance of CoPPs.
f. List of SOPs and STPs
g. Stability data (3 batches) Accelerated/Real-Time
h. List of equipment and Instruments
i. List of Technical Staff, their Qualification, Experience and approval status& Organogram.
j. Manufacturing Layout Plan.
k. Process Validation for 3 batches of each Product.
I. Schematic diagram of water system specifying circulation loop and MOC (Material of Construction), if not provided with Site Master File
m. Schematic diagram of HVAC system specifying terminal filter configuration (Specify Class A, B, C, D etc.), if not provided with Site Master File
Product Summary Sheet (Annexure B):-
Name of the product
Number of batches produced in the last two years (with scale R&D/Pilot/ Commercial)
Stability studies (maximum period completed) in months
Status of Process Validation
Status of Analytical Method Validation
If the product is approved by DCGI
(Completed/ Not completed)
(Completed/ Not completed)
i. Recommendation for issuance/further compliance /rejection of CoPP by the CDSCO Zonal or Sub-zonal office shall be forwarded to the concerned SLAs as per the following timeline:
a. When no joint inspection is required — 21 working days
b. When the joint inspection is required — 28 working days
ii. Based on the recommendations of a joint inspection team, CDSCO & SLA, COPP shall be issued within 5 days.
C. First-time Applicant for WHO-GMP (CoPP):
The joint inspection shall be planned by officers of Zonal or Sub-zonal and State Licensing Authorities (SLAs) after review of documents submitted under Annexure A and Annexure B. CoPP shall be issued when the firm had made necessary compliance to the deficiencies observed during such inspection, (if any) as per procedures laid down in 47th DCC minutes.
iii. Application for additional product to the WHO-GMP (CoPP):
For those firms which have been previously jointly inspected within two years by officers of CDSCO zonal or sub-zonal and State Licensing Authorities (SLAs) and found to comply with requirements of applicable WHO TRS guidelines, WHO-CoPP shall be issued on providing the complete data of products as mentioned in Annexure B.
The inspection shall be carried out as per the guidelines laid down in eh DCC minutes, relevant inspection SOPs and self-appraisal checklist for compliance with respect to all current WHO TRS guidelines of GMP and report shall be prepared as per the guidance for GMP inspection report in the format of Appendix 1 with the categorisation of deficiencies as per Appendix 11 of Annex 4 of WHO TRS 996.
This circular/document is to be treated as dynamic for updation as per suggestions and new developments, the circular further added
You can read the circular by clicking on the following link