Are you complying with the European Commission’s new version of Annex 16?
By Deb Bartel,
This post was recently updated on September 19, 2018
In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical supply chains and the introduction of new quality control strategies. Annex 16 was last published in 2001, so this version has significant improvements.
The deadline for compliance with this version of Annex 16 is 15-APR-2016.
What’s in this new version:
This version implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorization (MIA) interpretation document.
Annex 16 now specifically allows for the use of validated computerized systems as safeguards to ensure that uncertified batches of medicinal products are not transferred to saleable stock.
Download the new version here: Eudralex V4 Annex 16 Certification by a Qualified Person and Batch Release
Not sure how to interpret the changes in this regulation? Talk to our CSV experts about how it may affect project.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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