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

Drug Makers Catch FDA’s Drift, Look to Rid Processes of Variability

This article was originally published in The Gold Sheet

Executive Summary

FDA officials say that drug manufacturers need to have better trending and monitoring programs in place to detect process drift in drug manufacture. They note that many of the controls needed to prevent process drift are already embodied in existing GMP regulations but are underutilized.

You may also be interested in...



FDA Guidance Exempts Legacy Products from Early Stage Process Validation; Endorses Use of PAT

FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.

FDA Guidance Exempts Legacy Products from Early Stage Process Validation; Endorses Use of PAT

FDA’s final process validation guidance clarifies that legacy products, or products that are currently on the market, will be exempt from early stage process validation. The guidance also endorses the use of process analytical technology for monitoring product quality.

FDA Proposes to Ease Reporting Burden for Low-Risk CMC Changes

FDA relaxes approach to 40 types of low-risk manufacturing changes.

Latest News
See All
UsernamePublicRestriction

Register

PS000573

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