pharmaceutical validation certification

How to Monitor Vendor Performance After Qualification

How to Monitor Vendor Performance After Qualification How to Monitor Vendor Performance After Qualification The ongoing monitoring of vendor performance after qualification is a crucial aspect of pharmaceutical validation certification. Maintaining compliance with regulatory expectations such as FDA guidelines and…

Cross-Contamination Risk Assessment in Shared Facilities

Cross-Contamination Risk Assessment in Shared Facilities Cross-Contamination Risk Assessment in Shared Facilities Step 1: Understanding User Requirements Specification (URS) and Risk Assessment In the context of pharmaceutical validation, the User Requirements Specification (URS) acts as the foundational document that delineates…