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www.biopharminternational.com Quality and Regulatory Sourcebook March eBook 2023 BioPharm International ® 29 Validation Procedure Lifecycle <1220>, USP Stimuli Article, Phar- macopeial Forum 2017 43(1). 7. Burgess, C.; Curry, P.; LeBlond, D.J.; et al., Fitness for Use: Decision Rules and Target Measurement Uncertainty, USP Stimuli Article, Pharmacopeial Forum 2016 42(2). 8. Barnett, K.L.; Mcgregor, P.L.; Martin, G.P.; et al., Analyt- ical Target Profile: Structure and Application Through- out the Analytical Lifecycle, USP Stimuli Article, Phar- macopeial Forum 2016 42(5). 9. Martin, G.P.; Barnett, K.L.; Burgess, C.; et al., Lifecy- cle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification, USP Stimuli Article, Pharmacopeial Forum 2013 39(5). 10. USP. General Chapter <1220> Analytical Procedure Lifecycle, United States Pharmacopeia 2022. 11. Borman, P.; Roberts, J.; Jones, C.; et al. The Development Phase of an LC Method Using QbD Principles. Separa- tion Science. 2010 2 2–8. 12. Hanna-Brown, M; Borman, P.; Bale, S; Jones, J. Develop- ment of Chromatographic Methods Using QbD Princi- ples, Separation Science. 2010, 2, 12–20. 13. EMA and FDA. EMA-FDA Pilot Program for Parallel Assessment of Quality by Design Applications, 2011. (accessed June 30, 2022). 14. Teasdale A., Borman, P.J.; Mullen A.K.. Regulatory Highlights. Org. Process Res. Dev. 2022. https://doi. org/10.1021/acs.oprd.2c00054. 15. ICH. ICH Draft Guideline Q2(R2) Validation of Analytical Procedures (ICH, 2022). 16. Nethercote, P.; Borman, P.; Bennett, T.; Martin G.; Mc- Gregor P., QbD for Better Method Validation and Trans- fer, Pharma Manufacturing 2010. 17. FDA. Guidance for Industry. Process Validation: General Principles and Practices (CDER, 2011). 18. ICH. ICH Draft Guideline Q13 Continuous Manufacturing of Drug Substance and Drug Products (ICH, 2021). 19. JCGM. International Vocabulary of Metrology-Basic and General Concepts and Associated Terms (VIM). 4th Edition, 2021.■ Fit for Use Risk of being wrong Probability Decision Rule, Measurand & ATP Target Measurement Uncertainty Ongoing Analytical Procedure Performance Verification FIGURE 1. Relationship among the various tools and approaches, where the purpose of the analytical procedure informs all the following steps. Implications of Q14 and Q2(R2) draft guidelines The impact International Council for Harmonisation (ICH) Q14 and Q2(R2) draft guidelines on United States Pharma- copeia (USP) <1220> include: • No additional expectations or mandated requirements are expected in Q14, Q2(R2) and USP <1220>. The minimal approach can still be used. • Q14 and Q2(R2) are consistent with the principles described in USP <1220>, but not in full agreement. • Although Q14/Q2(R2) represent great progress towards implementation of sound science and QRM, their publica- tion as separate documents still leaves some gaps since a comprehensive and continuous APLC is not presented. For more information on the implications of ICH Q14 and Q2(R2) draft guidelines on United States Pharmacopeia chapters and other compendial activities, visit BioPharmInternational.com.