Analytical Development, R&D, Hovione FarmaCiência S.A, Campus do Lumiar, Edifício R, Estrada do Paço do Lumiar, 1649-038, Lisboa, Portugal.
Institute for Biotechnology and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Avenida Av. Rovisco Pais, 1, 1049-001, Lisbon, Portugal.
AAPS PharmSciTech. 2021 Apr 9;22(3):128. doi: 10.1208/s12249-021-01960-9.
The adoption of Quality by Design (QbD) and Analytical Method Lifecycle Management (AMLM) concepts to ensure the quality of pharmaceutical products has been applied and proposed over the last few years. These concepts are based on knowledge gained from the application of scientific and quality risk management approaches, throughout method lifecycle to assure continuous improvement and high reliability of analytical results. The overall AMLM starts with the definition of the method's intended use through the Analytical Target Profile definition, including three stages: (1) Method Design, taking advantage of the well-known concept of QbD; (2) Method Performance Qualification; (3) Continued Method Performance Verification. This is intended to holistically align method variability with product requirements, increasing confidence in the data generated, a regulatory requirement that the pharmaceutical industry must follow. This approach views all method-related activities, such as development, validation, transfer, and routine use as a continuum and interrelated process, where knowledge and risk management are the key enablers. An increase in method robustness, cost reduction, and decreased risk failures are some of the intrinsic benefits from this lifecycle management. This approach is clearly acknowledged both by regulators and industry. The roadmap of the regulatory and industry events that mark the evolution of these concepts helps to capture the current and future expectation of the pharmaceutical framework.
近年来，为确保药品质量，已采用并提出了质量源于设计（QbD）和分析方法生命周期管理（AMLM）概念。这些概念基于通过科学和质量风险管理方法在整个方法生命周期中的应用所获得的知识，以确保分析结果的持续改进和高可靠性。整体 AMLM 从通过分析目标概况定义定义方法的预期用途开始，包括三个阶段：（1）方法设计，利用 QbD 的知名概念；（2）方法性能资格认证；（3）持续的方法性能验证。这旨在将方法的可变性与产品要求全面对齐，提高对生成数据的信心，这是制药行业必须遵循的监管要求。这种方法将所有与方法相关的活动（如开发、验证、转移和常规使用）视为一个连续的、相互关联的过程，其中知识和风险管理是关键的推动因素。方法稳健性的提高、成本的降低和风险故障的减少是这种生命周期管理的一些内在收益。监管机构和行业都明确认可了这种方法。标志着这些概念发展的监管和行业事件路线图有助于捕捉制药框架的当前和未来预期。
