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

Lack of Microbiological Controls Had Grave Consequences for Compounders

This article was originally published in The Gold Sheet

Executive Summary

The current public health crisis stemming from microbiological contamination of sterile injectables at drug compounding pharmacies demonstrate the importance of having robust aseptic sterile processing programs, said an FDA official. Some problems at drug manufacturers were also highlighted showing inadequate microbiological controls.

You may also be interested in...



FDA Drug GMP Warning Letters Increase 6%, Focus on Supply Chain and Sterility Assurance in FY 2011

The number of drug GMP warning letters issued by FDA continued to climb in fiscal year 2011, with supply chain and sterility assurance issues dominating the agency’s attention. FDA is requesting a budget increase in FY 2013 to expand its inspectional presence abroad to better meet global supply chain threats, and agency officials are saying that failure to monitor contract manufacturers is a major problem shown in recent warning letters, but that failure to investigate out-of-specification results is still the No. 1 finding.

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.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS000649

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