Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

すべての製薬製造プロセスの品質を管理するPQMS Quascentaは、PQMSソフトウェアスイートを通じて、プロセス（Process）の品質（Quality）を管理（Management）する包括的なスイート（Suite）エコシステムを推進しています。このような製薬製造の品質エコシステムの ...

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

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 ...

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 ...

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.

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 ...