On 11 April 2016 a draft Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (“the Draft Guideline”) were published by the European Medicines Agency (“EMA”).

This Guideline will replace Decision trees for the selection of sterilisation methods, the Annex to the note for guidance on development pharmaceutics and the Annex “Decision trees for the selection of sterilisation methods” to the note for guidance Development pharmaceutics for veterinary medicinal products.


Sterilisation procedure is an element of quality of medicinal products. It cannot be guaranteed by testing so it is achieved through the use of suitable and validated manufacturing process.

Sterility is subject to different factors such as:

  • Bioburden of the formulation components;
  • Sterilisation procedure;
  • Integrity of the container closure system;
  • Use of satisfactory aseptic technique, where aseptic processing is required.

Draft guideline

The provisions of the Draft Guideline will apply to documents for sterile products for biological and chemical medicinal products, for both human and veterinary use. The concept of the Draft Guideline refers only to absence or removal of bacteria and funghi.

The Draft Guidelines introduce requirements for documentation of methods for sterilisation which need to be included in the quality dossier of a medicinal product. Requirements, however, only refer to justification of selected method whereas the choice of the method remains free.

Methods of sterilisation covered by the Draft Guideline are:

  • Steam sterilisation;
  • Dry heat sterilisation;
  • Ionization radiation sterilisation;
  • Gas sterilisation;
  • Sterile filtration;
  • Aseptic processing.

The Draft Guidelines includes decision trees which have been developed for products which contain chemical substance, but are also applicable to other type of products. Decision trees refer to sterilisation choices for aqueous products and non-aqueous liquid, semi-solid or dry powder products.