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
UsernamePublicRestriction

Process Validation Draft Praised Though Closer Alignment with ICH Supported

This article was originally published in The Gold Sheet

Executive Summary

Industry reacts to draft process validation guidance calling for FDA to, among other things, align it more closely to international principles, relax requirements for early-stage development, ease requirements for viral clearance studies, clarify that existing products would not have to be revalidated and ratify the standard three-batch approach as a minimum requirement.

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.

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

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.

UsernamePublicRestriction

Register

LL1135415

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