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: http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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
ReplyDeleteThat's good. Thumbs up for your efforts.
ReplyDelete