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

EU Inspectors to Focus on Integrity of Process Validation Data

This article was originally published in The Gold Sheet

Executive Summary

The revised Annex 15 is prompting EU inspectors to take a new look at data integrity problems. One EU inspector warns industry to be vigilant in looking for such problems in validation reports, and shares some news about Europe’s three-batch minimum for process validation.


Related Content

Industry Urges EU to Align Draft Validation Guidance with ICH and FDA





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