Wednesday, 8 May 2019

New sterile manufacturing guidance published by EMA

The European Medicines Agency (EMA) has published the final version of “Sterilisation of the medicinal product, active substance, excipient and primary container” (EMA/CHMP/CVMP/QWP/850374/2015), which first appeared in draft form in 2016. The document was published on 8th March 2019 and becomes effective from 1st October 2019.

The guidance describes the selection of appropriate methods of sterilisation for sterile products. The guidance discusses the importance of terminal sterilisation and the use of alternative methods for producing sterile products when terminal sterilisation cannot be undertaken (that is using sterilising filtration or aseptic processing, or a combination of the two). Where terminal sterilisation cannot be adopted, a robust rationale needs to be provided. For new products, the document outlines the appropriate decision-making process that is to be followed and the requirements needed for the marketing authorisation application (or a variation application) for a new or updated medicinal product. Central to the decision-making process is risk assessment and risk acceptance, within the overall context of quality risk management.

I will be analysing the implications in a forthcoming review article.

For details, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology


  1. Tim - the link was for the current guide (2008 corrected 2009). I am not able to see any sign of the new Annex 1. Were you perhaps referring to the new Annex 2 for Biological Active Substances. Trevor Deeks

  2. That's good. Thumbs up for your efforts.


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