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Sterility is a critical quality attribute for all sterile substances, products and containers. Sterility cannot be assured by testing, it needs to be assured by the use of a suitably designed, validated and controlled manufacturing process. Sterility is achieved by controlling several factors such as the
safety testing (e.g., for excipients and leachables) is also addressed. Additional quality aspects (e.g., impurities, process validation, stability testing, specifications) as well as safety and efficacy aspects, are described in other guidance documents, including ICH guidelines.
Guidance is provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers in a new marketing authorisation application or a variation application for a medicinal product.
5 Ιουν 2024 · 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.
This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation for ….
Issued in April 2016 for public comment, the document is titled Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container1. The key points...
9 Αυγ 2021 · Maintenance of sterility is required on container closures for aseptically processed product and sterile barrier packaging for terminally sterilized medical devices. Sterility assurance and/or packaging professionals need to optimize technologies; process validation, including test methods and design validation; samples sizes with statistical ...
