The Central Drugs Control Standards Organization (CDSCO) has recently issued a Circular directing all vaccine and sterile product manufacturers to implement various WHO TRS Guidelines, including WHO TRS 1044 Annexure 2 “WHO Good Manufacturing Practices for sterile pharmaceutical products,” which are published periodically. These guidelines are to be adopted after conducting a thorough gap analysis against the requirements outlined in Schedule M.
A Copy of the Circular is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
