Guideline on the sterilisation of the medicinal product

The European Medicines Agency has introduced a new draft guideline entitled "Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container."  The document was issued in April 2016.

As the introduction to the document states: “Sterility is a critical quality attribute for all sterile products. Sterility of the medicinal product cannot be assured by testing; it needs to be assured by the use of a suitable and validated manufacturing process. Sterility is dependent on several factors such as the bioburden of the formulation components, the sterilisation procedure, the integrity of the container closure system, (abbreviated as container in this document), and in the case of aseptic processing, the use of satisfactory aseptic technique.”

The document looks at the following processes:

• Steam sterilisation
• Dry heat sterilisation
• Ionisation radiation sterilisation
• Gas sterilisation
• Sterile filtration
• Aseptic processing

The document can be found here.



Posted by Dr. Tim Sandle