Given the importance of sterile products, in providing both a therapeutic medicine and with regards to the necessity of being free from viable microorganisms, pyrogenic substances and visible particulates, no new guidance has been issued by a regulatory authority in recent years. This has changed with a new draft guidance document from the European Medicines Agency. Issued in April 2016 for public comment, the document is titled Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container.
The key points are reviewed in an article for GMP Review by Tim Sandle. The reference is:
Sandle, T. (2016) New EMA draft guideline on sterilisation of the medicinal product, GMP Review, 15 (2): 6-8
Posted by Dr. Tim Sandle