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49 PIC/S Inspectorates Test-Drive Data Integrity Guidance

 
• By Joanne S. Eglovitch

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.

PIC/S Committee meeting, in Kiev (Ukraine), 2012
The PIC/S Committee, shown here meeting in Kiev, Ukraine, in 2012, has approved draft data integrity guidance for six-month trial implementation among member inspectorates. • Source: Photo courtesy of PIC/S. Reprinted with permission.

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.

The Pharmaceutical Inspection Cooperation Scheme issued its 41-page draft guideline on a trial basis Aug. 10 to the...

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UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
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