Abstract：
Multi-attribute methods employing mass spectrometry are applied throughout the biopharmaceutical industry for product and process characterization purposes but are not yet widely accepted as a method for batch release and stability testing under the good manufacturing practice (GMP) regime, due to limited experience and level of comfort with the technical, compliance and regulatory aspects of its implementation at quality control (QC) laboratories. This article is the second part of a two-tiered publication aiming at providing guidance for implementation of the multi-attribute method by peptide mapping liquid chromatography mass spectrometry (MAM) in a QC laboratory. The first part [1] focuses on technical considerations, while this second part provides considerations related to GMP compliance and regulatory aspects. This publication has been prepared by a group of industry experts representing 14 globally acting major biotechnology companies under the umbrella of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing & Quality Expert Group (MQEG).
摘要：
采用质谱的多属性方法在整个生物制药行业中用于产品和工艺表征目的，但尚未被广泛接受为良好生产规范（GMP）制度下的批量释放和稳定性测试方法。由于技术经验和舒适度有限，在质量控制（QC）实验室实施的合规性和监管方面。本文是两层出版物的第二部分，旨在为在QC实验室中通过肽图液相色谱质谱（MAM）实施多属性方法提供指导。第一部分[1]主要介绍技术方面的考虑,而第二部分提供了与GMP合规性和监管方面相关的注意事项。本出版物由一组行业专家编写，代表14家全球主要生物技术公司，隶属于欧洲制药工业协会联合会（EFPIA）制造和质量专家组（MQEG）。
