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.
You may also be interested in...
Qualified persons should respond to the complexities of globalization by leveraging quality systems rather than confirming every detail, Pfizer official says. Proposed revision to Annex 16 of EU GMPs defines numerous tasks QPs can delegate.
BARDA and Development Financing Corp. officials provide insights into window of opportunity for partnering on manufacturing scale-up.
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.