28/29 September 2021
The United States Pharmacopeia (USP) is currently introducing some changes not only to the format of the USP and its online platforms, but also to various chapters and so called stimuli articles. Some of these are also relevant for storage and transport activities:
The last one in the list gives guidance on useful elements for risk assessments within the distribution chain. It does not only focus on temperature but also on other factors like vibration, pressure and shock.
The use of The Use of Mean Kinetic Temperature (MKT) as a tool to evaluate temperature excursions often causes a lot of discussions. And the method has its limitations. In the stimuli article, USP points out that the method "should be used only once while a product is in the possession of an organization. Multiple excursions must be evaluated by the manufacturer"! In the General Chapter, USP also emphasises that the "idea that a temperature excursion above a product's storage temperature can be 'fixed' just by lowering the temperature of a warehouse for an appropriate period of time so that the resulting MKT calculation would provide an acceptable value" is not an option. This would ignore "the fact that any degradation due to the higher temperature is not reversible".
All new Pharmacopeial Forum (PF) content will be provided on the new PF Online platform. Access to Pharmacopeial Forum (PF) online is free of charge. Submitting comments to recent drafts is only possible via the new platform.