Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Difficulty Identifying Experts Seen as a Factor in Poor Investigations

This article was originally published in The Gold Sheet

Executive Summary

Pharmaceutical enterprises have become so complex that some sites with quality problems can’t find the root cause because they no longer know who their key experts are or where to find them, one industry expert says. Regardless of why they happen, inadequate investigations continue to be the most frequently cited GMP concern in FDA warning letters year after year.

You may also be interested in...



Hikma Should Revisit Investigations, FDA Warning Says

Continued problems at a Portuguese plant have prompted the U.S. FDA to urge Hikma to make a global reassessment of its manufacturing processes.

Contamination, Mix-Ups Drive Up Drug Recall Totals for 2012

Injectables eclipsed oral solids as 2012 generated the fourth-most recalls ever. Contamination played a major role, particularly in generating several massive recalls at compounding pharmacies, while there were also contraceptive packaging snafus, problems in confronting tablet mix-ups and other issues that generated drug recalls last year.

Contamination is Major Problem Seen in GMP Warning Letters

FDA’s aggressive enforcement against pharmaceutical manufacturers for GMP violations continued in the first half of the year through its use of warning letters. Inadequate contamination controls was a common deficiency found in eight of the 18 drug GMP warning letters, failure to investigate out-of-specification results continues to be the most frequent GMP deficiency in warning letters, and cites of stability problems are increasing.

Related Content

Topics

UsernamePublicRestriction

Register

PS000777

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