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Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).
Phil Borman* is director, Product Development & Supply at GSK.
Fumiko Tamura is associate manager, GSK, CMC Regulatory Affairs, Tokyo, Japan
Hatsuki Asahara is department manager with GSK, CMC Regulatory Affairs, Tokyo, Japan
Adam Watkins is scientific leader, GSK, product development and supply, David Jack Research Centre, Ware, UK.
Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
Validation of analytical procedures requires study of intermediate precision for within-laboratories variations; however, there is no global guidance on how to develop such designs. By applying science- and risk-based principles-aligned with quality by design (QbD)-to analytical procedures, studies can be designed to ensure the factors selected present the highest risk of impacting the performance of the analytical procedure. In addition, the number of independent analytical runs to include in these designs should be linked to the overall risk/complexity associated with the analytical procedure.
Useful pre-QbD guidance (provided by the Japanese National Institute of Health Sciences) proposed the use of a generic design which utilizes six independent analytical runs. Examples are provided which instead link the design structure and the number of independent analytical runs to the risk.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as P.J. Borman, et al., “Risk-Based Intermediate Precision Studies for Analytical Procedure Validation," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).