OR WAIT null SECS
July 02, 2016
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
June 24, 2016
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
June 16, 2016
The agency provides quality, development, manufacturing, and labeling recommendations.
June 15, 2016
Computerized systems can solve some of the data integrity problems with conventional paper-based systems.
June 13, 2016
The agency published guidance on the nonclinical evaluation of osteoporosis treatments.
June 09, 2016
The agency publishes three final guidance documents on drug compounding.
June 02, 2016
Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.
June 01, 2016
FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.