药用产品良好生产规范指南.docxVIP

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 药品检验公约 药品检验合作计划 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I 药用产品良好生产规范指南第一部分 目录 TOC \o 1-3 \h \z \u HYPERLINK \l _Toc443655484 第一章 质量管理 PAGEREF _Toc443655484 \h 2 HYPERLINK \l _Toc443655485 第二章人员 PAGEREF _Toc443655485 \h 11 HYPERLINK \l _Toc443655486 第三章 厂房设施 PAGEREF _Toc443655486 \h 17 HYPERLINK \l _Toc443655487 第四章 文件 PAGEREF _Toc443655487 \h 25 HYPERLINK \l _Toc443655488 第五章 生产 PAGEREF _Toc443655488 \h 41 HYPERLINK \l _Toc443655489 第六章质量控制 PAGEREF _Toc443655489 \h 53 HYPERLINK \l _Toc443655490 第七章 委托生产与委托检验 PAGEREF _Toc443655490 \h 62 HYPERLINK \l _Toc443655491 第八章 产品投诉和召回 PAGEREF _Toc443655491 \h 66 HYPERLINK \l _Toc443655492 第九章 自检 PAGEREF _Toc443655492 \h 69 CHAPTER 1 第一章 质量管理 QUALITY MANAGEMENT PRINCIPLE 原则 The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the manufacturing authorisation and for the authorised person(s). 生产许可证持有人必须生产药品，从而确保