Sterile medicinal products can be produced by one of two methods: terminal
sterilisation (which is the method of choice for regulators) or aseptic
processing (which carries greater inherent risks). While aspects of sterile
product manufacturing are described in the EU Guidelines to Good Manufacturing
Practice (GMP) Annex 11 (currently being re-drafted), European guidance on how
to select the most appropriate sterilisation method has not been updated for
several years. This lack of activity in relation to sterile product manufacture
has now been addressed.
In
relation to this topic, Tim Sandle has written an article for GMP Review:
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.
The
reference is:
For a copy, please contact Tim Sandle
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
No comments:
Post a Comment
Pharmaceutical Microbiology Resources