IPEC 药用辅料数据完整性立场文件20200430.pdfVIP

IPEC Position Paper Data Integrity for Pharmaceutical Grade Excipients 30 April 2020 Purpose of Position Paper This paper describes IPEC’s position on the relevance of data integrity guidance documents to the manufacture and supply of excipients. NOTE: Within this paper, supplier will refer to both the excipient manufacturer and distributor The Issue Current regulatory guidance documents on data integrity emphasize drug products (DP, also known as medicinal products) and drug substances (DS, also known as active pharmaceutical ingredients, APIs). Their scope does not explicitly include or exclude excipients. However, since critical data, Good Manufacturing Practice (GMP) compliance, and confidence in the quality of the excipient is based on the integrity of data, it is important for all parties involved in the manufacture and supply of excipients (e.g. warehousing, distributing, testing and packaging) to develop and implement appropriate strategies to manage the integrity of critical data in order to provide confidence in the quality and GMP compliance of the excipient. Many excipients are produced in facilities that manufacture products for a variety of markets (e.g., pharmaceutical, food, cosmetic and industrial). The manufacturing controls and instruments probably were: • designed for products other than excipients • designed and constructed with some open access components • built with sophisticated process automation systems designed to handle highly hazardous materials • primarily designed for manufacturing efficiency and compliance with environmental, occupational health and process safety regulations • installed before data integrity expectations were explicitly defined. Background Information Maintaining data integrity is fundamental to the application of GMP. Published regulatory guidance defines data integrity requirements for finished d