关键词: font-size:medium, ">GMP；物料检验；豁免

Abstract: The implementation of "Pharmacopoeia of the People′s Republic of China" (2020 edition) has strengthened the inspection to various medicinal raw and auxiliary materials and Chinese herbal medicines， and the implementation of "Good Manufacturing Practice for Drugs" (2010 edition) has strengthened the standard requirements for authenticity， integrity and reliability of the data. Informatization leads the modernization of drug management， especially the laboratory information management system(LIMS)， document management system (DMS)， and quality management system (QMS)， which are closely related to drug inspection， further standardize the compliance of the inspection process. The compliance of material inspection process and records with GMP scope put forword higher requirement for quality control (QC) personnel. How to reasonably and compliantly reduce the burden of QC personnel and avoid excessive quality management is an urgent problem to be solved at present. In view of this， this study is based on sufficient risk assessment and in compliance with the requirements of the Pharmacopoeia and GMP and other norms and standards， to sort out and analyze the conditions for exemption of material inspection， especially the scope， principles， and release procedures of material inspection exemption， and put forward suggestions that CNAS certification has positive significance for the applicable conditions of material inspection exemption， reasonably reducing the repeated inspection of materials， and realizing that materials can be exempted from inspection in some cases， providing a reference for the quality management of drug manufacturers.

Key words: font-size:medium, ">GMP； Material inspection； Exemption