Drug Regulators, EMA (EMEA), Publishes Draft Guidance on Real Time Release Testing (Parametric Release).
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Medicinal products must comply with the approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the finished product, according to the approved specifications. Under certain conditions, an alternative strategy to routine testing is possible. So far this concept has been only applied to sterility testing of terminally sterilised products (parametric release). Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made possible to apply a similar release strategy to tests other then sterility, this approach has been called Real Time Release testing.
This guideline addresses the requirements for application of RTR testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline replaces the previous guideline on parametric release and does not introduce new requirements, so the parametric release part on the previous guideline is retained unchanged.
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