Module 3 Presentations

07/05/2024

What is stability testing?

Real-Time stability testing – normally performed for longer duration of the test period to allow significant product degradation under recommended storage conditions Accelerated stability testing – product is stressed at several high (warmer than ambient) temperatures or another condition that accelerates degradation (e.g. moisture, light, agitation) – amount of heat input required to cause product failure is determined – information is projected to predict shelf life or used to compare the relative stability of alternative formulations

The Organisation for Professionals in Regulatory Affairs

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What is stability testing?

Retained sample stability testing – usual practice for every marketed product for which stability data is required – at least one batch a year Cyclic temperature stress testing – not a routine testing method for marketed products – cyclic temperature stress tests are designed on knowledge of the product so as to mimic likely conditions in market place storage – period of cycle mostly considered is 24 hours since the diurnal rhythm on earth is 24 hour, which the marketed pharmaceuticals are most likely to experience during storage

The Organisation for Professionals in Regulatory Affairs

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