PharmTech

The End of Process Validation As We Know It?

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors. In 1987, when the US Food and Drug ...
PharmTech

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...
PharmiWeb

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider ...
Business Wire

Process Validation Guidance Requirements: FDA and EU Annex 15: Qualifications and Validation - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...