Sterilisation medicinal products, active substances, excipients and primary containers

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:

Sandle, T. (2019) Sterilisation medicinal products, active substances, excipients and primary containers, GMP Review, 18 (1): 4-7

For a copy, please contact Tim Sandle



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology