Tag: gxp system validation process

Regulatory Expectations for External Service Qualification

Regulatory Expectations for External Service Qualification Regulatory Expectations for External Service Qualification In the highly regulated landscape of pharmaceuticals and biologics, the qualification of external service providers is a vital component of the gxp system validation process. This guide will…

Microbial Control During Dirty Hold Periods

Microbial Control During Dirty Hold Periods Microbial Control During Dirty Hold Periods Effective microbial control during dirty hold periods is critical to ensuring the safety and efficacy of pharmaceutical products. This article serves as a comprehensive guide on implementing a…