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

FDA Advises Starting With the Lab When Sniffing Out Data Integrity

This article was originally published in The Gold Sheet

Executive Summary

FDA official advises starting with laboratories when auditing contract manufacturers for data integrity. Recent warning letters and WHO notice of concern show why.

You may also be interested in...



Apotex Withdraws 31 ANDAs After Failing To Ensure Data Integrity At Two Indian Manufacturing Plants

Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.

Fresenius Kabi Hit With Two Warning Letters At Sites In India In December

New Year’s resolutions anyone? Generic drug maker Fresenius Kabi closed out the year with the unlucky distinction of receiving not one – but two – drug GMP warning letters from FDA last month. The agency chastised the firm for not reporting failing test results and not getting to the root cause of sterility failures. The firm was also criticized for not learning from earlier mistakes.

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS000812

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