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 Lapses Continue To Bedevil Manufacturers

This article was originally published in The Gold Sheet

Executive Summary

A recent compilation of FDA warning letters shows that data integrity failings continue to plague API and finished drug manufacturing sites in Asia and Europe.

You may also be interested in...



Ipca On Tailspin After Three-Plant FDA Ban

Ipca Laboratories was pummeled on Indian bourses after the US FDA barred all but one product from three of its facilities that have been grappling with compliance-related issues, piling up more pressure on the firm.

How To Audit Contract Manufacturers For Data Integrity Breaches

With data integrity problems on the rise, pharmaceutical manufacturers must ensure in auditing their contract manufacturing partners that they have the robust electronic controls needed to survive an FDA inspection. The analytical lab is a good place to start when doing audits because it's where a majority of problems are found by FDA investigators.

FDA Warning Letter Slams Another Asian API Firm On Data Integrity

Data integrity warning letter to Chinese API maker reflects continuing focus of FDA enforcement efforts on the pharmaceutical industry's Asian supply chain.

Topics

Latest News
UsernamePublicRestriction

Register

PS000995

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