58 Implementation of Schedule M and WHO Technical Report Series 2024-Aug-07 845 KB
File No. QMS/38/Misc/2024 Directorate General of Health Services Central Drugs Standard Control Organization (QMS Monitoring Division)
Dated:
Circular
Q 7 AUb 2024
Subject: Implementation of Schedule M and WHO Technical Report Series (TRS) - regarding.
This is with reference to revision of Schedule M vide GSR No. 922(E) dated 28.12.2023 and various WHO TRS guidelines including WHO TRS 1044 Annexure2 “WHO good manufacturing practices for sterile pharmaceutical products” which are published by WHO from time to time.
In this regard, it is requested that all manufacturers should take necessary steps for compliance with respect to various requirements as per above guidelines after due gap analysis.
This is for information and necessary compliance.
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----- Start of picture text -----<br> Yours faithfully,<br>l ote<br>----- End of picture text -----<br>
(Dr. Rajeev Singh Kaghuvanshi) Drugs Controller General (India)
To
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All vaccine manufacturers/Sterile product manufacturers.
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All State Drugs Controllers.
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All Zonal / Sub Zonal offices of CDSCO.
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CDSCO website.
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DCG(I) guard file.
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