21 CFR Part 11 : Electronic Records & Signatures
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…
Media Fill Test – Aseptic Process Simulation in Micro
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.…
Regulatory Audit : Preparation & Handling
Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0 PURPOSE The purpose…