Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Latest FDA Drug GMP Warning Letters Target CEOs, Contract Manufacturers

This article was originally published in The Tan Sheet

Executive Summary

Six of FDA's last nine drug GMP warning letters went to contract manufacturing facilities, including firms making OTC drugs and dietary supplements.

You may also be interested in...



The Return of Part 11

FDA July 7 alerted industry that the agency will soon begin conducting inspections focused on compliance with its March 1997 Part 11 rule on electronic records and electronic signatures

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns

Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS104771

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel