An organization of 49 of the world's foremost pharmaceutical inspectorates has launched a six-month trial implementation of a guideline that could set the standard globally for enforcing data integrity in pharmaceutical manufacturing.
49 PIC/S Inspectorates Test-Drive Data Integrity Guidance
Pharmaceutical Inspection Cooperation Scheme member inspectorates are trying out the most comprehensive manufacturing data integrity guidance yet developed. Issued amid a flurry of guidance from various authorities, it could play a key role in harmonizing regulatory approaches.
More from Manufacturing
More from Compliance
• By
The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
• By
An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.
• By
Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA