ECA Guide for the Evaluation and Investigation of Microbiological Deviations
: 21 Jul 2020
The pharmaceutical microbiology working group of the ECA decided two years ago to prepare a supporting document providing guidance on how to deal with microbiological deviations.
Chapter 1 “Guidance for deviation handling of microbiological environmental monitoring excursions in non-sterile pharmaceutical manufacturing” has already been published.
Chapter 2 "Endotoxin testing lab investigations - Out of specification (OOS)/ Out of trend (OOT) / Atypical results investigations" will be published shortly.
Delivered by Jordi Iglesias, Technology and Market Development Manager, Charles River this webinar will examine Chapter 2.