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Final PIC/S Data Integrity Guidance Encourages Foolproof Approaches To Drug Manufacturing Data

 
• By Bowman Cox

Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.

The human element plays a role in data integrity.
when to avoid the human element in data integrity • Source: Alamy

The Pharmaceutical Inspection Cooperation Scheme leavened the final version of its guidance on data integrity, published 1 July, with provisions encouraging the use of software that removes the human element from the flow of data – and the lack of integrity that can go with it.

PIC/S developed the guidance on pharmaceutical manufacturing and distribution data integrity – the most comprehensive yet published – mainly to help inspectors assess compliance, but also with an eye to...

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• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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• By Jessica Merrill

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

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Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
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More from Compliance

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.