Διαφήμιση
σχετικά με: excipient and primary container sterilityAmazingly popular! Durable polypropylene construction with clear base lets you see inside. Depend on Uline – your #1 source of storage containers, bins, shelving and racking.
Αποτελέσματα Αναζήτησης
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
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.
Update January 2019: This Q&A has been superseded by the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. Please refer to this guideline for further information.
It is possible to apply for a CEP for a sterile substance in the following conditions: - The substance shall be sterile and shall comply with the test for sterility 2.6.1 described in. the European Pharmacopoeia.
This includes the required documentation for sterile finished products, but also for sterile active ingredients and excipients and sterile primary packaging. This concerns meeting authorisation application as well as variation application.
Eudralex Volume 3 Sterilisation of the medicinal product, active substance, excipient and primary container. EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel (44-20-7) 418 8400, Fay (44-20-7) 418 85 95. This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing ...
9 Αυγ 2021 · Maintenance of sterility is required on container closures for aseptically processed product and sterile barrier packaging for terminally sterilized medical devices.
Διαφήμιση
σχετικά με: excipient and primary container sterilityAmazingly popular! Durable polypropylene construction with clear base lets you see inside. Depend on Uline – your #1 source of storage containers, bins, shelving and racking.
