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

FDA Collates GMP Data Integrity Advice Into New Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

New Q&A-format draft guidance could help stave off the missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: if data is generated to satisfy a CGMP requirement, then it is a CGMP record that must be retained.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS079313

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to 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

Add a personalized Question to your Analyst

Cancel