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An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation1. In this context, risk is defined as the combination of the probability of occurrence of harm (or unwanted outcome) and the…
Whereas the existing ICH quality documents covering impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B (R2)) provide a framework for the qualification and control of most commonly encountered impurities and degradants, it is recognised that lower thresholds may be appropriate if the impurity is unusually toxic…
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…
22 October 2013 | By David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca
Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) .
