A “stability budget” is being proposed by a PDA task force as a viable approach for industry in its efforts to fill an important gap in assuring the quality of pharmaceutical products through the full-length of their distribution process.
The stability budget essentially combines relevant information from temperature excursion and cycling studies with the available data from standard long-term and accelerated stability testing to determine the amount of time a drug substance or product can spend out of the normal/labeled storage conditions without significant risk to its quality. The “budget” for the excursions in the distribution process factors in the shelf life and user stability needs.
Key to the approach is a broadening of the focus from what happens during “transportation” to the entire distribution process, including the time products spend in the warehouse and other storage locations.
The stability budget proposal was presented by Lilly Principal Regulatory Consultant and task force co-leader Robert Seevers and Lilly colleague and task force member Paul Harber at the PDA Cold Chain Management Conference in Bethesda, Maryland in early March.
Reflecting a growing regulatory emphasis on product control during distribution, the task force was convened by PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG) following the 2010 cold chain conference to develop guidance on the stability testing needed to support the distribution process beyond the confines of the existing ICH guidelines.
The task force is proposing that the draft document it has developed incorporating the stability budget concept be adopted as a PDA Technical Report, with the ultimate goal of bringing the report forward to ICH with PhRMA backing as an extension of the ICH Q1 stability series. The draft is now working its way through the PDA clearance process.
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