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

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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