News about GMP/cGMP


EMA Publishes Sterile Manufacturing Guidance

In March 2019, the European Medicines Agency (EMA) published the 25-page final version of the guideline "Sterilisation of the Medicinal Products, Active Substance, Excipient and Primary Container". The document will enter into force on 1 October 2019.

The selection of appropriate sterilsation methods for sterile products is explained. The importance of sterilisation in the final container, according to the reference conditions described in Ph.Eur., is highlighted as the preferred method. However, alternative methods are also being discussed, such as the use of sterile filtration or aseptic processing (alone or in combination with additional heat sterilisation after sterile processing). For the use of these alternative methods, a science-based justification is expected, which should be documented accordingly.
The document comprises the

  • sterilisation by steam, dry heat and ionising irradiation according to the reference conditions of Ph. Eur. 5.1.1
  • sterilisation by filtration and aseptic processing  and the
  • sterilisation by gas.

The optimal selection of a suitable sterilisation process is supported by decision trees. The schemes shown are for

  • aqueous products
  • dry powder products, non-aqueous liquid or semi-solid products, and for
  • containers.

For new products, the document describes an appropriate assessment process and the requirements for the marketing authorisation application (or variation application) of a new or modified medicinal product. The focus is on risk assessment and risk acceptance in the overall context of quality risk management.
The guideline applies to chemical and biological medicinal products for human and veterinary use, but does not apply to immunological veterinary medicinal products.


EMA: Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container