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www.biopharminternational.com Quality and Regulatory Sourcebook March eBook 2023 BioPharm International ® 19 Validation worldw ide orga n izat ions/associat ions, has been promoting the AQbD principles that may transform t he qua l it y c u lt u re by enabl i ng a nd suppor t i ng in novat ion for bot h sma l l molecu le a nd biologi- cal medicines (7,27–29). The British Pharmacopoeia (BP) has also been playing an important role in this transformation. In 2014, an AQbD working party was established and a new supplementary chapter "Ap- plication of AQbD to Pharmacopoeial Methods" was published in BP 2022 (30). In 2019, a consultation was also published by BP and the United Kingdom's Med- icines and Healthcare products Regulatory Agency (MHRA) to explore the inclusion of AQbD elements in compendial monographs and the consultation re- sponse became public available in 2020 (31). A case study was also published in 2019 with focus on the practical application of AQbD principles to the de- velopment of an assay procedure for ator vastatin in atorvastatin tablets (32). The atorvastatin tablets monograph was published in BP 2023 including two AQbD elements (ATP and MODR) as non-compendial tools. USP is also working on creating practical case studies to explore how AQbD elements may be in- cluded in monographs in the f uture, with the aim to provide the industry with additional knowledge for proper procedure performance verification and QRM, allowing for continuous quality improvement. USP and BP chapters are informational chapters and aim to provide guidance for the implementation of enhanced approaches to support APLC management. The European Pharmacopeia launched in 2022 a call for volunteers for a new working party on AQbD (33). The APLC concept also underlies the standard ISO/ IEC 17025 (34). Figure 3 shows the evolution of QbD considering relevant guidelines. FDA has not provided specific guidance on how to implement the APLC approach; however, chapter VIII of the FDA guidance on AP validation published in 2015 (35) mentions the life cycle management of AP and highlights the importance of trend analysis for procedure performance and use of risk assess- ment for procedure development and validation. A few other existing USP general chapters cover principles and considerations for some stages of the APLC (e.g., <1225> Validation of Compendial Proce- dures (36), <1226> Verification of Compendial Proce- dures (37), <1224> Transfer of Analytical Procedures (38), <1210> Statistical Tools for Procedure Validation (39), <1039> Chemometrics (40), and <1010> Analyt- ical Data - Interpretation and Treatment (41)). USP <1010> includes statistical approaches for proce- dures comparability (e.g., equivalence of means and USP GC <1225> Compendial Procedure Validation FDA Draft Guidance for Industry "Analytical Procedures and Methods Validation" ICH Q2 FDA Guideline on General Principles of Process Validation FDA Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach ICH guidelines outline QbD concepts 2004: Q8 Pharmaceutical development 2005: Q9 Quality risk managment 2007: Q10 Pharmaceutical quality system 2012: Q11 Development and manufacture of DS EFPIA PhRMA publications EMA & FDA Pilot Program for Parallel Assessment or applications FDA Guidance for Industry. "Process Validation: General Principles and Practices." Revision 1 USP Verification and Validation Expert Panel ICH Q12 Pharmaceutical Product Lifecycle Management FDA Guidance for Industry. " Analytical Procedures and Methods for Drugs and Biologics" ICH Q14/Q2(R2) EWG USP <1220> published in PF46(5) USP <1220> became online in USP-NF Public Consultation ICH Q14 draft guideline Procedure Development ICH Q2(R2) draft guideline Procedure Validation USP <1220> became official May 1, 2022 FDA FDA OBP Pilot Program FDA OMDQA CMC Pilot program EMA "Guideline on Process Validation" draft BP AQbD Working Party USP Stimuli Articles PF 39(5) Lifecycle Management of AP PF 42(2) Fitness for Use PF 42(5) ATP PF 42(5) ACS PF 44(1) MU for the Pharmaceutical Industry PF 45(6) Distinguishing the Analytical Method from the Analytical Procedure to Support the USP APLC Paradigm BP/MHRA AQbD Consultation FDA Report on the state of pharmaceutical quality - NIPP and QMM initiatives BP Supplementary chapter on AQbD proposed EP Call for Volunteers - AQbD Working Party 1989 2007 - 2010 2013 2014 2013 - 2019 2019 - 2020 2020 2021 2022 2022 1987 1994 - 1996 2004 - 2012 2000 2004 2005 2008 2011 2012 2014 - 2017 2014 - 2015 2018 2021 March 2022 Error! Reference source not found.. Timeline with publication of International Council for Harmonisation (ICH) guidelines outlining quality by design (QbD), United States Pharmacopeia (USP)/British Pharmacopoeia (BP) chapters, and FDA/EMA guidelines related to process and analytical procedures validation and/or life cycle. FIGURE 3. Timeline with publication of International Council for Harmonisation (ICH) guidelines outlining quality by design (QbD), United States Pharmacopeia (USP)/British Pharmacopoeia (BP) chapters, and FDA/EMA guidelines related to process and analytical procedures validation and/or life cycle. FIGURES COURTESY OF THE AUTHORS.