摘要
Abstract
Objective To provide a reference for improving China's drug regulations.Methods The differences of the material sampling requirements of the main text and Appendix 8(starting material and packaging material sampling,hereinafter referred to as Appendix 8)in the Good Manufacturing Practice(GMP)of Pharmaceutical Inspection Co-Operation Scheme(PIC/S)with those in the China's GMP main text and Appendix 9(sampling),the Chinese Pharmacopoeia(2020 Edition)and national standards were analyzed.Key differences were discussed and researched,and improvement suggestions were proposed.Results Material sampling was attached great importance in both GMPs,but PIC/S GMP had more detailed requirements for personnel training,and the design requirement descriptions for sampling methods were macroscopic based on risk factors;while China's GMP had macroscopic requirements for personnel training,the design requirements for sampling methods were classified,and more details were provided in other technical documents such as the Chinese Pharmacopoeia.A total of 439 survey questionnaires were distributed and effectively collected,involving 439 manufacturing enterprises related to biological products(including vaccines),chemical drug injections,traditional Chinese medicine(TCM)injections,ordinary chemical drug preparations,active pharmaceutical ingredients(APIs)and TCM decoction pieces;58 enterprises(13.21%)conducted sampling and testing per package,while the rest conducted sampling and testing;409 enterprises(93.17%)did not know how to verify or thought the verification was costly and difficult for ″ensuring the correct labeling of each package of starting materials″;358 enterprises(81.55%)thought that a material sampling plan should be established based on supplier audits.Field research was conducted in Sichuan,Yunnan,Jiangsu and Chongqing,involving 14 manufacturing enterprises related to TCM(including injections),chemical drug preparations,APIs,and biological products(including vaccines);seven enterprises(50.00%)conducted sampling and testing per package for injection raw materials;TCM(including injections)manufacturing enterprises thought that starting materials cannot be sampled and tested per package;eight enterprises(57.14%)thought that establishing a sampling plan based on supplier audits and material risk assessments was feasible.Conclusion It is recommended to increase the requirements for sampling and testing per package for injection raw materials and materials that cannot be traced back to the manufacturers;some samples should be extracted for testing following the original sampling statistical requirements for Chinese medicinal materials and decoction pieces,and relevant manufacturer enterprises should pay attention to the supply chain management of medicinal materials;the requirements should be added to conduct risk assessments based on the material properties,supplier qualification confirmation,and the uniformity of the materials themselves,and establish a material sampling plan based on approved sampling procedures.关键词
药品检查合作计划/药品生产质量管理规范/物料取样/差异分析Key words
Pharmaceutical Inspection Co-Operation Scheme/Good Manufacturing Practice/material sampling/differential analysis分类
医药卫生
