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

Rule is First Step in FDA Effort to Rescue GMPs from the 1970s

This article was originally published in The Gold Sheet

Executive Summary

POST-1970s DRUG CGMPs begin taking shape with FDA’s first revision in more than a decade. Gone are references to asbestos and certain pre-automation work processes. In are some new provisions that conform to current practices and that harmonize with other nations’ regulations. FDA’s last major attempt to revise the cGMPs, an ill-fated 1996 proposal, is formally withdrawn, clearing the way to further conform U.S. cGMPs with emerging quality systems approaches.

You may also be interested in...



FDA and EMA Revising GMP Regulations to Address Supply Chain Deficiencies

FDA, EMA revising GMPs to establish supply chain controls. FDA looks to require identification and auditing of ingredient suppliers, heightened component security, notification of significant defects. EMA to require detailed API supply chain pedigrees and more technical agreements. QPs will have to really vouch for API sites. FDA also plans other GMP changes.

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

UsernamePublicRestriction

Register

PS000181

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