Extractables and Leachables Implementation Dates

December 1st 2005

Plastic and packaging impurities guideline EMA/CHMP/CVMP

March 1st 2009

Eudralex, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use: Annex 1, Manufacture of Sterile Medicinal Products

August 25th 2023

GMP Annex 1 Revision - Manufacture of Sterile Medicinal Products. 


You can check Socosur Tox methodology for Extractables and Leachables Risk Assessments, signed by an European Registered Toxicologist expert here.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Socosur Tox is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using this email link to receive a quotation for Tox Extractables and Leachables procedure used on your manufacturing line.