In this video TJ Woody, IPS' Associate Director of Cleaning and Processing Validation, discusses the move to risk management in the handling of products within a manufacturing facility. Specifically, he discusses the revisions to the Eudralex’s EU Guidelines for Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use, Volume 4 . One of the reasons for the revision is to improve the guidance on prevention of cross-contamination and inclusion of a toxicological assessment.The key difference from the previous version is the statement that the measures to prevent cross-contamination should be commensurate with the risks.
To read more go to http://www.pharmpro.com/videos/2014/02/ips-tech-tips-episode-1-understanding-new-eu-cross-contamination-guidance
