Sterilisation of the medicinal product, active substance, excipient and primary container - Scientific guideline

Guidance is provided on the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur.) is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional post-aseptic processing terminal heat treatment), could be accepted as an alternative. Guidance is provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers in a new marketing authorisation application or a variation application for a medicinal product.

This guideline replaces the previous annexes to Pharmaceutical development Decision trees for the selection of sterilisation methods, (human and veterinary). It also revises the information on methods of sterilisation previously described in the note for guidance on manufacture of the finished dosage form (human and veterinary).

This guideline applies to human and veterinary medicines.

Keywords: Active substance, aseptic processing, container, decision trees, excipients, filtration, finished dosage form, sterilisation, sterilisation assurance level, terminal sterilisation, post-aseptic processing terminal heat treatment

Effective from 01/08/1999 – 01/10/2019

Effective from 01/09/2000 – 01/10/2019

Effective from 01/04/2001 – 01/10/2019