Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 11 of 54

12 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Analytical Procedure Validation V alidation of analytical procedures requires study of in- termediate precision for within-laboratories variations; however, there is no global guidance on how to develop such designs. By applying science- and risk-based prin- ciples—aligned with quality by design (QbD)—to analytical proce- dures, 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 associ- ated with the analytical procedure. Useful pre-QbD guidance (pro- vided 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. The long-established International Council for Harmonization (ICH) Q2 guideline (1) sets out the characteristics for consideration when validating analytical procedures as part of registration applica- tions submitted within Europe, Japan, and the United States. Inter- mediate precision (IP) is the second of three levels for the precision characteristic as described by ICH Q2; the others are repeatability and reproducibility. The guideline notes, "Intermediate precision expresses within-laboratories variations: different days, different analysts, dif- ferent equipment, etc." Additionally, ICH Q2 provides some high-level guidance on the extent of how much IP is established and advises Risk-Based Intermediate Precision Studies for Analytical Procedure Validation Phil Borman, Marion Chatfield, Hatsuki Asahara, Fumiko Tamura, and Adam Watkins Validation of analytical procedures requires 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. Phil Borman* phil.j.borman@, is director, product development and supply, and Marion Chatfield is director, CMC statistics, both with GSK, Medicines Research Centre, Stevenage, UK; Hatsuki Asahara is department manager and Fumiko Tamura is associate manager, both with GSK, CMC Regulatory Affairs, Tokyo, Japan; and Adam Watkins is scientific leader, GSK, product development and supply, David Jack Research Centre, Ware, UK. *To whom all correspondence should be addressed. Looker_Studio -

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