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PIC/S Wants To Know: What About ‘Authorized Persons’ For Batch Release Outside The EU?

 
• By Bowman Cox

International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.

Microbiological bioreactor. Cultivation of microorganisms. Bio-fermentation. Bioengineering. Vaccine production. Creation of medicines. Pharmacology. Laboratory equipment. - Image
who is qualified to release batches

An international association of 54 pharmaceutical inspectorates has asked its non-EU members to consult with industry and perhaps the public on a plan to embrace the EU’s reliance on designated company personnel to certify pharmaceutical batches for release.

The consultation may lead many regulatory authorities and industry to re-think the question of who decides whether drugs and biologics...

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