Container Closure Testing
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ICH Q5C Stability testing of Biotechnological / Biological ...
admin.ich.org30 ICH Q5C - Stability testing of Biotechnological / Biological products Bracketing (IV) Container closure size and /or fills • Applicable without justification with same container closure system where either size or fill varies. • If both container and fill vary, largest or smaller container may not represent the extremes of all packaging.
Annex 5 Guidelines for stability testing of pharmaceutical ...
www.paho.orgMain objectives of stability testing Objective Type of study Use To select adequate (from the viewpoint of stability) formulations and container-closure systems Accelerated Development of the product To determine shelf-life and storage conditions Accelerated and real-time Development of the product and of the registration dossier
Q8(R2) - ICH
database.ich.orgexcipients, container closure system, any relevant dosing device), the manufacturing process, and, if appropriate, knowledge gained from the development of similar drug product(s). Any excipient ranges included in the batch formula (3.2.P.3.2) should be justified in
active substance, excipient and primary container ...
www.ema.europa.eube 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 bioburden, the sterilisation procedure, the integrity of the …