【正文】 DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA美國FDA原料藥生產(chǎn)質(zhì)量管理規(guī)范（中英文）Table of Contents 目錄1. INTRODUCTION簡介 Objective 目的 Regulatory Applicability法規(guī)的適用性 Scope 范圍2. QUALITY MANAGEMENT .質(zhì)量管理 Principles 總則 Responsibilities of the Quality Unit(s) 質(zhì)量部門的責(zé)任 Responsibility for Production Activities 生產(chǎn)作業(yè)的職責(zé) Internal Audits (Self Inspection) 內(nèi)部審計（自檢） Product Quality Review 產(chǎn)品質(zhì)量審核3. PERSONNEL 人員 Personnel Qualifications 人員的資質(zhì) Personnel Hygiene 人員衛(wèi)生 Consultants 顧問4. BUILDINGS AND FACILITIES 建筑和設(shè)施 Design and Construction 設(shè)計和結(jié)構(gòu) Utilities 公用設(shè)施 Water 水 Containment 限制 Lighting 照明 Sewage and Refuse 排污和垃圾 Sanitation and Maintenance 衛(wèi)生和保養(yǎng)5. PROCESS EQUIPMENT 工藝設(shè)備 Design and Construction 設(shè)計和結(jié)構(gòu) Equipment Maintenance and Cleaning 設(shè)備保養(yǎng)和清潔 Calibration. 校驗 Computerized Systems 計算機控制系統(tǒng)6. DOCUMENTATION AND RECORDS 文件和記錄 Documentation System and Specifications 文件系統(tǒng)和質(zhì)量標(biāo)準(zhǔn) Equipment cleaning and Use Record 設(shè)備的清潔和使用記錄 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials原料、中間體、原料藥的標(biāo)簽和包裝材料的記錄 Master Production Instructions (Master Production and Control Records)生產(chǎn)工藝規(guī)程（主生產(chǎn)和控制記錄） Batch Production Records (Batch Production and Control Records)批生產(chǎn)記錄（批生產(chǎn)和控制記錄） Laboratory Control Records 實驗室控制記錄 Batch Production Record Review 批生產(chǎn)記錄審核7. MATERIALS MANAGEMENT 物料管理 General Controls 控制通則 Receipt and Quarantine 接收和待驗 Sampling and Testing of Ining Production Materials 進(jìn)廠物料的取樣與測試 Storage 儲存 Reevaluation 復(fù)驗8. PRODUCTION AND INPROCESS CONTROLS 生產(chǎn)和過程控制 Production Operations 生產(chǎn)操作 Time Limits 時限 Inprocess Sampling and Controls 工序取樣和控制 Blending Batches of Intermediates or APIs 中間體或原料藥的混批 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料藥和中間體的包裝和貼簽 General 總則 Packaging Materials 包裝材料 Label Issuance and Control 標(biāo)簽發(fā)放與控制 Packaging and Labeling Operations 包裝和貼簽操作10. STORAGE AND Warehousing Procedures 入庫程序 Distribution Procedures 分發(fā)程序11. LABORATORY CONTROLS 實驗室控制 General Controls 控制通則 Testing of Intermediates and APIs 中間體和原料藥的測試 Validation of Analytical Procedures 分析方法的驗證 Certificates of Analysis分析報告單 Stability Monitoring of APIs 原料藥的穩(wěn)定性監(jiān)測 Expiry and Retest Dating 有效期和復(fù)驗期 Reserve/Retention Samples 留樣12. VALIDATION .驗證 Validation Policy 驗證方針 Validation Documentation 驗證文件 Qualification 確認(rèn) Approaches to Process Validation 工藝驗證的方法 Process Validation Program 工藝驗證的程序 Periodic Review of Validated Systems 驗證系統(tǒng)的定期審核 Cleaning Validation 清洗驗證 Validation of Analytical Methods 分析方法的驗證13. CHANGE CONTROL 變更的控制14. REJECTION AND REUSE OF Rejection 拒收 Reprocessing 返工 Reworking 重新加工 Recovery of Materials and Solvents 物料與溶劑的回收 Returns 退貨15. COMPLAINTS AND RECALLS 投訴與召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)協(xié)議生產(chǎn)商（包括實驗室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、經(jīng)紀(jì)人、貿(mào)易商、經(jīng)銷商、重新包裝者和重新貼簽者 Applicability 適用性 Traceability of Distributed APIs and Intermediates已分發(fā)的原料藥和中間體的可追溯性 Quality Management 質(zhì)量管理 Repackaging, Relabeling, and Holding of APIs and Intermediates原料藥和中間體的重新包裝、重新貼簽和待檢 Stability 穩(wěn)定性 Transfer of Information 信息的傳達(dá) Handling of Complaints and Recalls 投訴和召回的處理 Handling of Returns 退貨的處理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用細(xì)胞繁殖/發(fā)酵生產(chǎn)的原料藥的特殊指南 General 總則 Cell Bank Maintenance and Record Keeping 細(xì)胞庫的維護(hù)和記錄的保存 Cell Culture/Fermentation 細(xì)胞繁殖/發(fā)酵 Harvesting, Isolation and Purification 收取、分離和精制 Viral Removal/Inactivation steps 病毒的去除/滅活步驟19. APIs for Use in Clinical Trials 用于臨床研究的原料藥 General 總則 Quality 質(zhì)量 Equipment and Facilities設(shè)備和設(shè)施 Control of Raw Materials 原料的控制 Production 生產(chǎn) Validation 驗證 Changes 變更 Laboratory Controls 實驗室控制 Documentation 文件20. Glossary 術(shù)語1. INTRODUCTION 1. 簡介 Objective This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在為在合適的質(zhì)量管理體系下制造活性藥用成分（以下稱原料藥）提供有關(guān)優(yōu)良藥品生產(chǎn)管理規(guī)范（GMP）提供指南。它也著眼于幫助確保原料藥符合其旨在達(dá)到或表明擁有的質(zhì)量與純度要求。In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. In this guidance, the term should identifies remendations that, when followed, will ensure pliance with CGMPs. An alternative approach may be used if such approach satisfies the requirements of the applicable statues. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent.本指南中所指的“制造”包括物料接收、生產(chǎn)、包裝、重新包裝、貼簽、重新貼簽、質(zhì)量控制、放行、原料藥的儲存和分發(fā)及其相關(guān)控制的所有操作。本指南中，“應(yīng)當(dāng)”一詞表示希望采用的建議，除非證明其不適用或者可用一種已證明有同等或更高質(zhì)量保證水平的供選物來替代。本指南中的“現(xiàn)行優(yōu)良生產(chǎn)管理規(guī)范（cGMP）”和“優(yōu)良生產(chǎn)管理規(guī)范（GMP）”是等同的。The guida