USP revises Storage and Transport Chapters

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:

General Chapters

• [1079] Good Storage and Distribution Practices for Drug Products
• [1079.2] Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
• [659] Packaging and Storage Requirements

Stimuli Article

• The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions for Controlled Cold Temperature Drugs: Proper and Improper Application
• The Use of Simulated Transport in the Evaluation of Risks to the Product Quality from the Distribution Process

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".

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