As Annex 16 Revision Proceeds, QPs Urged to Focus on Quality Systems in Certifying Batches
This article was originally published in The Gold Sheet
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.
You may also be interested in...
Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to COVID-19-related travel restrictions to continue on a routine basis.
International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.