Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API &…
Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR…
Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test.…