Requirements for Sterile Packaging Material

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline on "Content of the dossier for sterile substances". The document is available for public consultation until 15 August 2024. After the consultation phase the final guideline will be made available on the EDQM website. 

Sterilisation of Packaging - What needs to be provided?

The revised Annex 1 (Manufacture of Sterile Medicinal Products) of the EU GMP Guide includes information on the application of GMP to sterile primary packaging material. In addition, details are required for the methods used to sterilise the packaging components. If the reference conditions of Ph. Eur. chapter 5.1.1. Methods of preparation of sterile products are not used, validation data for the sterilisation process of the packaging material should be provided. The requirements of the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container should be considered to determine the most appropriate method of sterilisation of the packaging components. The integrity of the packaging once filled with the sterile grade material should be validated. If a re-test period is claimed, results of stability studies are required as an assurance that sterility is maintained in the container.

For more information please see the Draft guideline on "Content of the dossier for sterile substances" released on the EQQM website.

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