Issue link: https://www.e-digitaleditions.com/i/1495138
www.biopharminternational.com Quality and Regulatory Sourcebook March eBook 2023 BioPharm International ® 17 Validation and controlling sources of variability (8). Further- more, existing guidance is often applied in a check- box manner, and default performance criteria are often established to satisf y compliance objectives, although the rationale for establishing the criteria is not always transparent. In other words, often no proper performance requirements are established to ensure fitness for use. In 2013, USP created the USP Verification and Valida- tion Expert Panel (EP) to envision the future of analyt- ical validation concepts. Later, this Panel became the USP Measurement & Data Quality Expert Committee. Several USP stimuli articles were published from 2013 to 2019, covering key aspects of the APLC. These include: • USP Pharmacopeial Forum (PF) 39(5) Lifecycle Management of Analytical Procedures (21) • USP PF 42(2) Fitness for Use (22) • USP PF 42(5) Analytical Target Profile(23) • USP PF 42(5) Analytical Control Strategy (24) • USP PF 44(1) Measurement Uncertainty for the Pharmaceutical Industry (25) • USP PF 45(6) Distinguishing the Analy tical Met hod f rom t he A na ly t ica l P rocedu re to Support the USP Analytical Procedure Life Cycle Paradigm (26). These articles incorporate QbD principles previously outlined in ICH Q8-Q12 and in publications by differ- ent associations such as the joint working groups of the European Federation of the Pharmaceutical Indus- tries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) (7,27). These articles built the basis for developing USP General Chapter <1220> Analytical Procedure Lifecy- cle, published in PF 46(5) Dec. 1, 2020 (official as of May 1, 2022, in USP-National Formulary). USP <1220> presents a holistic approach for APLC management and highlights the importance of sound scientific approaches and QRM for the development, control, establishment, and use of procedures to ensure fit- ness for use (28). The APLC approach is considered an enhanced approach driven by AQbD principles that provides connectivity between all stages of the APLC, allowing for proper knowledge management. "Analytical Quality by Design (AQbD) is asystem- atic approach to development that begins with pre- defined objectives and performance requirements (analytical target profile) and emphasizes procedure performance understanding and control, based on sound science and quality risk management. AQbD is derived from QbD principles and refers to the ap- plication of QbD in the APLC management allowing for the quality to be built into the procedure design." The major driver for adopting the life cycle ap- proach is to ensure that the reportable value is fit for use, because the reportable value provides the basis for key decisions regarding compliance of a product with regulator y, compendial, and manufacturing limits (28). Key questions that the industry usually needs to answer are: ICH Q13 ICH Q(R2) ICH Q12 ICH Q14 ICH Guidelines QbD Process Analytical Technologies (PATs) Real Time Release Tests Process Control Validation Expansion of the scope for other techniques Validation of multivariate procedures/models Knowledge Management vs Checkbox Exercise Real Time Release Tests Product Life Cycle Management Approaches for Analytical Procedures Change Minimal vs Enhanced Approaches forProcedure Development Analytical Procedure Life Cycle Management Quality Risk Management Post-Approval Changes of Analytical Procedures Multivariate Analytical Procedures Analytical Procedure Life Cycle The Quality Target Product Profiles (QTPP) Analytical Procedure 1 Analytical Procedure 2 Analytical Procedure n The Analytical Target Profile (ATP) Stage 1 Stage 2 Stage 3 Procedure Design Procedure Performance Qualification Ongoing Procedure Performance Verification Continued Improvement Knowledge Management FIGURE 1. Connectivity between the principles described in the most recent International Council for Harmonisation (ICH) Q guidelines which outline quality-by-design (QbD) principles.