Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

The author describes why statistical significance would impose an unreasonable burden on manufacturers. Validation has been practiced within the global healthcare industry since the early 1970s. While ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering.

この記事では、「PIC/S GMPが求めるバイオ医薬品の品質管理・品質保証のポイントと、バリデーションの立案・実施、さらに適格性評価の重要性」についてお話しします。 バイオ医薬品は、その製造工程の複雑さから、品質の一貫性を保つことが非常に重要です ...

The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the ...

DUBLIN--(BUSINESS WIRE)--The "Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering. This training ...