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

Data Integrity Problems Continued to Surface in Recent Warning Letters

This article was originally published in The Gold Sheet

Executive Summary

Recent GMP warning letters featured data integrity issues.

You may also be interested in...



Heat Treat Wooden Pallets to Avoid Taint of TBP, Drug Makers Told

Pharmaceutical manufacturers should use only heat-treated wooden pallets to ensure that they don’t have TBP-taints that can cause musty and moldy odors in plastic medicine bottles. There have been eight drug recall incidents since 2009 for smells emanating from TBP.

Contamination Issues Drove Drug Recalls to Record Levels in 2011

How contamination, sterility assurance, OOS and other issues caused drug recalls to spike again last year. What happened at Aidapak, H&P, Ben Venue, Hospira, Teva and other manufacturers to set a new record.

News in Brief

FDA hits heparin supply chain; Ranbaxy consents to data integrity oversight; multinationals find solutions to China’s vaccine compendial crisis; EU seeks comment on safety measures, API imports.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS000461

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