Transcription of Ongoing Stability Testing: Requirements, …
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Ongoing Stability Testing: Requirements, …
Ingredients, Formulations & FinishingAll medicinal products on the market must bemonitored in a continuous programme in order todemonstrate Stability and quality over their entiremarket life. Laboratory analysis is a cost factor that stilloffers room for manoeuvre in many companies, andwith improved study design, the burden of ongoingstability tests can be reduced. In the realisation of moreefficient Stability testing , however, it is important to beaware of the potential revised version of Chapter 1 of the EU GMPG uidelines (1) came into force in 2006; item makesthe annual Product Quality Review (PQR) compulsoryfor all licensed products. This continuous revision of theconsistency and validity of the entire manufacturingprocess also includes a Stability -monitoring programmeas listed under sub-item vii.
Ongoing studies are intended to prove that, over the period of its labelled shelf life and under ‘real life conditions’, the product remains of the quality defined in
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