After about 5 years of consultation the long expected GMP Annex 1 revision was finally published.

You can find a lot of new information in this updated version.

This new GMP Annex 1 is applicable as of

• 25 August 2023 except for chapter 8.123 
• 25 August 2024 for chapter 8.1.23 (lyophilizers)

You can find the document here: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

Please feel free to contact us at info@horn-pharma.de, if you like to know more. 

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de