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 Annexure 2 “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.
Click for Detail Information /Govt. Publications / Source: https://satvikam.in/wp-content/uploads/2024/10/Circular-Schedule-M.pdf