Tag: software validation fda

Qualification of Excipients and Critical Raw Materials

Qualification of Excipients and Critical Raw Materials Qualification of Excipients and Critical Raw Materials In the pharmaceutical and biopharmaceutical industries, the qualification of excipients and critical raw materials is a fundamental aspect of ensuring product quality, safety, and efficacy. This…

Case Study: Visual Inspection Failure and Root Cause Analysis

Case Study: Visual Inspection Failure and Root Cause Analysis Case Study: Visual Inspection Failure and Root Cause Analysis Step 1: User Requirements Specification (URS) & Risk Assessment The initial phase in the process validation lifecycle involves developing a User Requirements…