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28 BioPharm International ® Quality and Regulatory Sourcebook March eBook 2023 www.biopharminternational.com Validation of being wrong (or the probability of a reportable value not being fit for its purpose) is used to assess the risk of making the wrong decision about product compliance/ quality. The acceptable probability of being wrong; the clear, concise definition of what is being measured; and the acceptable range of results can be determined using the decision rule, measurand, and target mea- surement uncertainty and then can be included in the ATP. These items then guide the ongoing analytical procedure performance verification during routine use and also when changes are made. These relation- ships are shown in Figure 1. References 1. ICH. ICH Draft Guideline Q14 Analytical Procedure Development, 2022. 2. Schweitzer, M.; Pohl, M.; Hanna-Brown, M; Nether- cote, P., et al., Implications and Opportunities of Ap- plying QbD Principles to Analytical Measurements. Pharm.Technol. 2010 34 52–59. 3. Borman, P.; Chatfield, M.; Nethercote, P.; Thomp- son, D.; Truman, K. The Application of Quality by Design to Analytical Methods, Pharm.Technol. 2007 31, 142–152. 4. Kovacs, E.; Ermer, J.; McGregor, P.L.; et al., Analyt- ical Control Strategy, USP Stimuli Article, Pharma- copeial Forum 2016 42(5). 5. Weitzel, J.; Meija, J.; LeBlond, D.; Walfish, S. Measure- ment Uncertainty for the Pharmaceutical Industry, USP Stimuli Article, Pharmacopeial Forum 2018 44(1). 6. Martin, G.P.; Barnett, K.L.; Burgess, C.; et al., Pro- posed New USP General Chapter: The Analytical TABLE V. Comparison of terminology and elements between International Council for Harmonisation (ICH) Q14, Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 – Part II. Concept ISO ISO/IEC 17025 ICH Q14&Q2(R2) USP <1220> Measurand Included, see the International Vocabulary of Metrology (VIM) (19). "7.2.2.3 The performance characteristics of validated methods, as assessed for the intended use, shall be relevant to the customers' needs and consistent with specified requirements." "fit for its intended purpose: to measure an attribute or attributes of the analyzed material with the needed specificity/selectivity, accuracy and/or precision over the reportable range."(Q14) Demonstration of meeting the intended use as specified in the analytical target profile (ATP) through the analytical procedure life cycle (APLC). Measurement Uncertainty (MU) The GUM is the definitive metrological guide dealing with MU. Section 7.6 deals with MU. MU is used extensively. ICH mentions uncertainty in regard to the reference AP. USP <1220> and USP stimuli article (5) [5] include MU. Quality by Design The metrological MU (see GUM) is used extensively, while total analytical error (TAE) is not used. Uncertainty includes both systematic and random error. Uses MU. Uses TAE. TAE and MU are treated interchangeably. AP Qualification/ Method Validation Validation is a QMP. Section 7.2.2 Integral to Q14. Stage 2 in Life Cycle. Ongoing AP Verification Ensuring that the results meet customer requirements is a Quality Management Principle. Section 7.7, Ensuring the Validity of Results Included under AP Control Strategy. Stage 3 in Life Cycle. Statistical Process Control (SPC) SPC is part of the Quality Management Principles. Part of section 7.7 ICH Q14 does not address SPC specifically, e.g., it does not include control chart use. Part of stage 3. Regulations May or may not be required by relevant regulations. Voluntary standard ICH documents are guides, not standards, in the pharmaceutical industry. They may or may not be referenced by regulations. USP <1220> is an informational chapter.