Pink Sheet is part of the Business Intelligence Division 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

FDA: Early Process Validation Studies Could Avert Preapproval Inspection Findings

Executive Summary

FDA officials stress the importance of nailing down the design of manufacturing processes early on to support later-stage process validation studies. Investigators find many of the deficiencies noted in preapproval inspections stem from inadequate Stage 1 process validation work. The best process validation programs are the ones that employ robust risk management models that explore how multiple variables can affect the manufacturing process.

Advertisement

Related Content

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

Topics

Advertisement
UsernamePublicRestriction

Register

PS119273

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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