Tag: filter validation

Regulatory Expectations for Supplier Qualification (FDA, EMA, WHO)

Regulatory Expectations for Supplier Qualification (FDA, EMA, WHO) Regulatory Expectations for Supplier Qualification (FDA, EMA, WHO) 1. Understanding User Requirements Specification (URS) & Risk Assessment The first step in the filter validation lifecycle involves the development of a User Requirements…

Case Study: Swab Sampling for Complex Manufacturing Lines

Case Study: Swab Sampling for Complex Manufacturing Lines Case Study: Swab Sampling for Complex Manufacturing Lines Swab sampling is a critical component in the validation processes of pharmaceutical manufacturing, particularly in ensuring that complex production lines maintain their expected level…