Guidance on GMP & GDP: Q&A

The EMA has updated this Q&A relating to key GMP and GDP topics. Updates relate to two questions, which are questions 2 and 5:

EU GMP Guide Part 1 CH 5 Q2

 

This indicates that it is possible to use multiple batch numbers in packaging of medicinal products

 

Q5 relates to the requirements for batch numbers appearing on the packaging of medicinal products subject to parallel trade.

 

See: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)