ICH中英文對照版本

精品文檔 1歡迎下載 人用藥物注冊技術(shù)要求國際協(xié)調(diào)會議 I C H International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH 三方協(xié)調(diào)指南 原料藥的優(yōu)良制造規(guī)范 GMP 指南 ICH 指導(dǎo)委員會 2000 年 11 月 10 日按 ICH 規(guī)程第 4 步建議采用 本指南根據(jù) ICH 規(guī)程由合適的 ICH 專家工作組起草并經(jīng)向法規(guī)部門咨詢 在規(guī)程的第 4 步 建議歐洲共同體 日本和美國的藥政部門采用其最終的 草案 原料藥的優(yōu)良制造規(guī)范 GMP 指南 ICH 三方協(xié)調(diào)指南 ICH 指導(dǎo)委員會 2000 年 11 月 10 日的會議按 ICH 規(guī)程第 4 步 精品文檔 2歡迎下載 建議 ICH 的三個藥政部門采用本指南 目目 錄錄 1 引言 INTRODUCTION 6 1 1 目的 Objective 6 1 2 法規(guī)的適用性 Regulatory Applicability 7 1 3 范圍 Range 7 2 質(zhì)量管理 QUALITY MANAGEMENT 8 2 1 原則 Principles 8 2 2 質(zhì)量部門的職責(zé) Responsibilities of the Quality Unit s 9 2 3 生產(chǎn)作業(yè)的職責(zé) Responsibility for Production Activities 12 2 4 內(nèi)部審計(jì) 自檢 Internal Audits Self Inspection 13 2 5 產(chǎn)品質(zhì)量審核 Product Quality Review 13 3 人員 PERSONNEL 13 3 1 員工的資質(zhì) Personnel qualifications 14 3 2 員工的衛(wèi)生 Personnel Hygiene 14 3 3 顧問 Consultants 15 4 建筑和設(shè)施 BUILDINGS AND FACILITIES 15 4 1 設(shè)計(jì)和結(jié)構(gòu) Design and Construction 15 4 2 公用設(shè)施 Utilities 16 4 3 水 Water 17 4 4 限制 Containment 17 4 5 照明 Lighting 18 4 6 排污和垃圾 Sewage and Refuse 18 4 7 清潔和保養(yǎng) Sanitation and Maintenance 18 5 工藝設(shè)備 PROCESS EQUIPMENT 19 5 1 設(shè)計(jì)和結(jié)構(gòu) Design and Construction 19 5 2 設(shè)備保養(yǎng)和清潔 Equipment Maintenance and Cleaning 20 5 3 校驗(yàn) Calibration 21 5 4 計(jì)算機(jī)控制系統(tǒng) Computerized Systems 21 6 文件和記錄 DOCUMENTATION AND RECORDS 22 6 1 文件系統(tǒng)和規(guī)格 Documentation System and Specifications 22 6 2 設(shè)備的清潔和使用記錄 Equipment Cleaning and Use Record 24 精品文檔 3歡迎下載 6 3 原料 中間體 原料藥的標(biāo)簽和包裝材料的記錄 Records of Materials Intermediates API Labeling and Packaging Materials 24 6 4 生產(chǎn)工藝規(guī)程 Master Production Instructions 25 6 5 批生產(chǎn)記錄 Batch Production Records 25 6 6 實(shí)驗(yàn)室控制記錄 Laboratory Control Records 27 6 7 批生產(chǎn)記錄審核 Batch Production Record Review 28 7 物料管理 MATERIALS MANAGEMENT 28 7 1 控制通則 General Controls 28 7 2 接收和待驗(yàn) Receipt and Quarantine 29 7 3 進(jìn)廠物料的取樣和測試 Sampling and Testing of Incoming Production Materials 30 7 4 儲存 Storage 31 7 5 重新評估 Re evaluation 31 8 生產(chǎn)和中間控制 PRODUCTION AND IN PROCESS CONTROLS 31 8 1 生產(chǎn)操作 Production Operations 31 8 2 時間限制 Time Limits 32 8 3 工序間的取樣和控制 In process Sampling and Controls 33 8 4 中間體或原料藥的混合 Blending Batches of Intermediates or APIs 34 8 5 污染的控制 Contamination Control 35 9 原料藥和中間體的包裝和貼簽 PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 35 9 1 總則 General 35 9 2 包裝材料 Packaging Materials 36 9 3 標(biāo)簽的發(fā)放和控制 Labeling Issuance and Control 36 9 4 包裝和貼簽操作 Packaging and Labeling Operations 37 10 儲存和分發(fā) STORAGE AND DISTRIBUTION 38 10 1 入庫程序 Warehousing Procedures 38 10 2 分發(fā)程序 Distribution Procedures 38 11 實(shí)驗(yàn)室控制 LABORATORY CONTROLS 38 11 1 控制通則 General Controls 39 11 2 中間體和原料藥的測試 Testing of Intermediates and APIs 40 11 3 分析程序的驗(yàn)證 參見 12 章 Validation of Analytical Procedures See Section 12 11 3 41 11 4 分析報(bào)告單 Certificates of Analysis 41 11 5 原料藥的穩(wěn)定性監(jiān)測 Stability Monitorint of APIs 42 11 6 有效期和復(fù)驗(yàn)日期 Expiry and Retest Dating 43 11 7 留樣 Reserve Retention Samples 43 精品文檔 4歡迎下載 12 驗(yàn)證 VALIDATION 44 12 1 驗(yàn)證方針 Validation Policy 44 12 2 驗(yàn)證文件 Validation Documentation 44 12 3 確認(rèn) Qualification 45 12 4 工藝驗(yàn)證的方法 Approaches to Process Validation 45 12 5 工藝驗(yàn)證的程序 Process Validation Program 47 12 7 清洗驗(yàn)證 Cleaning Validation 47 12 8 分析方法的驗(yàn)證 Validation of Analytical Methods 49 13 變更的控制 CHANGE CONTROL 50 14 物料的拒收和再用 REJECTION AND RE USE OF MATERIALS 51 14 1 拒收 Rejection 51 14 2 返工 Reprocessing 51 14 3 重新加工 Reworking 52 14 4 物料和溶劑的回收 Recovery of Materials and Solvents 52 14 5 退貨 Returns 53 15 投訴和召回 COMPLAINTS AND RECALLS 53 16 協(xié)議制造商 包括實(shí)驗(yàn)室 CONTRACT MANUFACTURES INCLUDING LABORATORIES 54 17 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 55 AGENTS BROKERS TRADERS DISTRIBUTORS REPACKERS AND RELABELLERS 55 17 1 適用性 Applicability 55 17 2 已分發(fā)原料藥的可追溯性 Traceability of Distributed APIs and Intermediates 55 17 3 質(zhì)量管理 Quality Management 55 17 4 原料藥和中間體的重新包裝 重新貼簽和待檢 Repackaging Relabeling and Holding of APIs and Intermediates 56 17 5 穩(wěn)定性 Stability 56 17 6 信息的傳達(dá) Transfer of Information 56 17 7 投訴和召回的處理 Handing of Complaints and Recalls 57 17 8 退貨的處理 Handing of Returns 57 18 用細(xì)胞繁殖 發(fā)酵生產(chǎn)的原料藥的特殊指南 57 SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELL CULTURE FERMENTATION 57 18 1 總則 General 57 18 2 細(xì)胞庫的維護(hù)和記錄的保存 Cell Bank Maintenance and Record Keeping 60 18 3 細(xì)胞繁殖 發(fā)酵 Cell Culture Fermentation 60 18 4 收取 分離和精制 Harvesting Isolation and Purifation 61 精品文檔 5歡迎下載 18 5 病毒的去除 滅活步驟 Viral Removal Inactivation Steps 62 19 用于臨床研究的原料藥 APIS FOR USE IN CLINICAL TRIALS 62 19 1 總則 General 62 19 2 質(zhì)量 quality 63 19 3 設(shè)備和設(shè)施 Equipment and Facilities 63 19 4 原料的控制 Control of Raw Materials 64 19 5 生產(chǎn) Production 64 19 6 驗(yàn)證 Validation 64 19 7 變更 Changes 65 19 8 實(shí)驗(yàn)室控制 Laboratory Controls 65 19 9 文件 Documentation 65 20 術(shù)語表 GLOOSSARY 66 精品文檔 6歡迎下載 原料藥的優(yōu)良制造規(guī)范原料藥的優(yōu)良制造規(guī)范 GMP GMP 指南指南 GuidanceGuidance forfor IndustryIndustry Q7AQ7A GoodGood ManufacturingManufacturing PracticePractice GuidanceGuidance forfor ActiveActive PharmaceuticalPharmaceutical IngredientsIngredients This guidance represents the Food and Drug Administration s FDA s current thinking on this topic It does not create or confer any rights for or on any person and does not operate to bind FDA or the public An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations 1 1 引言引言 INTRODUCTIONINTRODUCTION 1 1 目的 Objective 本文件 指南 旨在為在合適的質(zhì)量管理體系下制造活性藥用成分 原料藥以下稱原料藥 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 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 在本指南中 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 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 recommendations that when followed will ensure compliance with CGMPs An alternative approach may be used if such approach satisfies the requirements of the applicable statutes For the purposes of this guidance the terms current good manufacturing practices and good manufacturing practices are equivalent 本指南在總體上未涉及生產(chǎn)人員的安全問題 亦不包括環(huán)保方面的內(nèi)容 這方面的管理是生產(chǎn)者固有的責(zé)任 也是國家法律規(guī)定的 The guidance as a whole does not cover safety aspects for the personnel engaged in manufacturing nor aspects related to protecting the environment These controls are inherent responsibilities of the manufacturer and are governed by national laws 本指南沒打算規(guī)定注冊 歸擋的要求 或修改藥典的要求 本指南不影響負(fù)責(zé)藥政審理部門在原料藥上市 制造 授權(quán)或藥品申請方面建立特定注冊 歸擋要求的能力 注冊 歸擋的所有承諾必須做到 This guidance is not 精品文檔 7歡迎下載 intended to define registration and or filing requirements or modify pharmacopoeias requirements This guidance does not affect the ability of the responsible regulatory agency to establish specific registration filing requirements regarding APIs within the context of marketing manufacturing authorizations or drug applications All commitments in registration filing documents should be met 1 2 法規(guī)的適用性 Regulatory Applicability 在世界范圍內(nèi)對原料藥的法定定義是各不相同的 當(dāng)某種物料在其制造或用于藥品的地區(qū)或國家被稱為原料藥 就應(yīng)該按照本指南進(jìn)行生產(chǎn) Within the world community materials may vary as to their legal classification as an API When a material is classified as an API in the region or country in which it is manufactured or used in a drug product it should be manufactured according to this guidance 1 3 范圍 Range 本文件適用于人用藥品 醫(yī)療用品 所含原料藥的制造 它適用于無菌原料藥在滅菌前的步驟 本指南不包括 無菌原料藥的消毒和滅菌工藝 但是 應(yīng)當(dāng)符合地方當(dāng)局所規(guī)定的藥品 醫(yī)療用品 生產(chǎn)的 GMP 指南 本文件適用于通過化學(xué)合成 提取 細(xì)胞培養(yǎng) 發(fā)酵 通過從自然資源回收 或通過這些工藝的結(jié)合而得到的原料 藥 通過細(xì)胞培養(yǎng) 發(fā)酵生產(chǎn)的原料藥的特殊指南則在第 18 章論述 This guidance applies to the manufacture of APIs for use in human drug medicinal products It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile The sterilization and aseptic processing of sterile APIs are not covered by this guidance but should be performed in accordance with GMP guidance for drug medicinal products as defined by local authorities This guidance covers APIs that are manufactured by chemical synthesis extraction cell culture fermentation recovery from natural sources or any combination of these processes Specific guidance for APIs manufactured by cell culture fermentation is described in Section XVIII 18 本指南不包括所有疫苗 完整細(xì)胞 全血和血漿 全血和血漿的衍生物 血漿成分 和基因治療的原料藥 但是 卻包括以血或血漿為原材料生產(chǎn)的原料藥 值得注意的是細(xì)胞酶解物 哺乳動物 植物 昆蟲或微生物的細(xì)胞 組 織或動物來源物 包括轉(zhuǎn)基因動物 和前期生產(chǎn)可能應(yīng)遵循 GMP 規(guī)范 但不包括在本指南之內(nèi) 另外 本指南不適 用于醫(yī)用氣體 散裝藥品 醫(yī)療用品 和放射性藥物的特殊的制造 控制 This guidance excludes all vaccines whole cells whole blood and plasma blood and plasma derivatives plasma fractionation and gene therapy APIs However it does include APIs that are produced using blood or plasma as raw materials Note that cell substrates mammalian plant insect or microbial cells tissue or animal sources including transgenic animals and early process steps may be subject to GMP but are not covered by this guidance In addition the guidance does not apply to medical gases bulk packaged drug medicinal products e g tablets or capsules in bulk containers or radiopharmaceuticals 第 19 章的指南只適用于用在藥品 醫(yī)療產(chǎn)品 生產(chǎn)中的原料藥制造 特別是臨床實(shí)驗(yàn)用藥 研究用醫(yī)療產(chǎn)品 的 原料藥制造 原料藥的起始物料 是指一種原料 中間體或原料藥 用來生產(chǎn)一種原料藥 或者以主要結(jié)構(gòu)單元 精品文檔 8歡迎下載 的形式被結(jié)合進(jìn)原料藥結(jié)構(gòu)中 原料藥的起始物料可能是在市場上有售 能夠通過合同或商業(yè)協(xié)議從一個或多個供 應(yīng)商處購得 或由生產(chǎn)廠家自制 原料藥的起始物料一般來說有特定的化學(xué)特性和結(jié)構(gòu) Section XIX 19 contains guidance that only applies to the manufacture of APIs used in the production of drug medicinal products specifically for clinical trials investigational medicinal products An API starting material is a raw material an intermediate or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API An API starting material can be an article of commerce a material purchased from one or more suppliers under contract or commercial agreement or produced in house API starting materials normally have defined chemical properties and structure 生產(chǎn)廠商要定義并用書面文件說明原料藥的生產(chǎn)從何處開始的理論依據(jù) 對于合成工藝而言 就是 原料藥的 起始物料 進(jìn)入工藝的那一點(diǎn) 對其他工藝 如 發(fā)酵 提取 純化等 可能需要具體問題具體對待 表 1 給出了原 料藥的起始物料從哪一點(diǎn)引入工藝過程的指導(dǎo)原則 The company should designate and document the rationale for the point at which production of the API begins For synthetic processes this is known as the point at which API starting materials are entered into the process For other processes e g fermentation extraction purification this rationale should be established on a case by case basis Table 1 gives guidance on the point at which the API starting material is normally introduced into the process 從這步開始 本指南中的有關(guān) GMP 規(guī)范應(yīng)當(dāng)應(yīng)用在這些中間體和 或原料藥的制造中 這包括對原料藥質(zhì)量 有影響的關(guān)鍵工藝步驟的驗(yàn)證 但是 值得注意的是廠商選擇某一步驟進(jìn)行驗(yàn)證 并不一定將該步驟定為關(guān)鍵步驟 本文件的指南通常適用于表 1 中的灰色步驟 這并不意味必需完成所有步驟 原料藥生產(chǎn)中的 GMP 要求應(yīng)當(dāng)隨著工 藝的進(jìn)行 從原料藥的前幾步到最后幾步 精制和包裝 越來越嚴(yán)格 原料藥的物料加工 如制粒 包衣或顆粒度 的物理處理 例如制粉 微粉化 至少應(yīng)當(dāng)按本指南的標(biāo)準(zhǔn)進(jìn)行 From this point on appropriate GMP as defined in this guidance should be applied to these intermediate and or API manufacturing steps This would include the validation of critical process steps determined to impact the quality of the API However it should be noted that the fact that a company chooses to validate a process step does not necessarily define that step as critical The guidance in this document would normally be applied to the steps shown in gray in Table 1 However all steps shown may not need to be completed The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps purification and packaging Physical processing of APIs such as granulation coating or physical manipulation of particle size e g milling micronizing should be conducted according to this guidance 本 GMP 指南不適用于引入定義了的 原料藥的起始物料 以前的步驟 This GMP guidance does not apply to steps prior to the introduction of the defined API starting material 精品文檔 9歡迎下載 2 2 質(zhì)量管理質(zhì)量管理 QUALITYQUALITY MANAGEMENTMANAGEMENT 2 1 原則 Principles 2 1 0 參與原料藥制造的每一個人都應(yīng)當(dāng)對質(zhì)量負(fù)責(zé) Quality should be the responsibility of all persons involved in manufacturing 2 1 1 每家制造商都應(yīng)當(dāng)建立 證明其有 并執(zhí)行一套有管理人員和有關(guān)員工積極參與的有效的質(zhì)量管理體系 Each manufacturer should establish document and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel 2 1 2 質(zhì)量管理體系應(yīng)當(dāng)包括組織結(jié)構(gòu) 程序 工藝和資源 以及確保原料藥會符合其預(yù)期的質(zhì)量與純度要求所必 需的活動 所有涉及質(zhì)量管理的活動都應(yīng)當(dāng)明確規(guī)定 并有文件證明 The system for managing quality should encompass the organizational structure procedures processes and resources as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity All quality related activities should be defined and documented 2 1 3 應(yīng)當(dāng)設(shè)立一個獨(dú)立于生產(chǎn)部門的質(zhì)量部門 同時履行質(zhì)量保證 QA 和質(zhì)量控制 QC 的職責(zé) 依照組織結(jié)構(gòu)的 大小 可以是分開的 QA 和 QC 部門 或者只是一個人或組 There should be a quality unit s that is independent of production and that fulfills both quality assurance QA and quality control QC responsibilities The quality unit can be in the form of separate QA and QC units or a single individual or group depending upon the size and structure of the organization 2 1 4 應(yīng)當(dāng)指定授權(quán)發(fā)放中間體和原料藥的人員 The persons authorized to release intermediates and APIs should be specified 2 1 5 所有有關(guān)質(zhì)量的活動應(yīng)當(dāng)在其執(zhí)行時就記錄 All quality related activities should be recorded at the time they are performed 2 1 6 任何偏離確定程序的情況都應(yīng)當(dāng)有文字記錄并加以解釋 對于關(guān)鍵性偏差應(yīng)當(dāng)進(jìn)行調(diào)查 并記錄調(diào)查經(jīng)過及 其結(jié)果 Any deviation from established procedures should be documented and explained Critical deviations should be investigated and the investigation and its conclusions should be documented 2 1 7 在質(zhì)量部門對物料完成滿意的評價(jià)之前 任何物料都不應(yīng)當(dāng)發(fā)放或使用 除非有合適的系統(tǒng)允許此類使用 如 10 20 條款所述的待檢情況下的使用 或是原料或中間體在等待評價(jià)結(jié)束時的使用 No materials should be released or used before the satisfactory completion of evaluation by the quality unit s unless there are appropriate systems in place to allow for such use e g release under quarantine as described in Section X 10 or the use of raw materials or intermediates pending completion of evaluation 2 1 8 應(yīng)當(dāng)有程序能確保公司的責(zé)任管理人員能及時得到有關(guān)藥政檢查 嚴(yán)重的 GMP 缺陷 產(chǎn)品缺陷及其相關(guān)活動 如質(zhì)量投訴 召回 藥政活動等 的通知 Procedures should exist for notifying responsible 精品文檔 10歡迎下載 management in a timely manner of regulatory inspections serious GMP deficiencies product defects and related actions e g quality related complaints recalls and regulatory actions 2 2 質(zhì)量部門的職責(zé) Responsibilities of the Quality Unit s 2 2 0 質(zhì)量部門應(yīng)當(dāng)參與所有與質(zhì)量有關(guān)的事務(wù) The quality unit s should be involved in all quality related matters 2 2 1 所有與質(zhì)量有關(guān)的文件應(yīng)當(dāng)由質(zhì)量部門審核批準(zhǔn) The quality unit s should review and approve all appropriate quality related documents 2 2 2 獨(dú)立的質(zhì)量部門的主要職責(zé)不應(yīng)當(dāng)委派給他人 這些責(zé)任應(yīng)當(dāng)以文字形式加以說明 而且應(yīng)當(dāng)包括 但不限 于 The main responsibilities of the independent quality unit s should not be delegated These responsibilities should be described in writing and should include but not necessarily be limited to 1 所有原料藥的放行和否決 用于制造商控制范圍以外的中間體的放行和否決 Releasing or rejecting all APIs Releasing or rejecting intermediates for use outside the control of the manufacturing company 2 建立一個放行或拒收原材料 中間體 包裝材料和標(biāo)簽的系統(tǒng) Establishing a system to release or reject raw materials intermediates packaging and labeling materials 3 在供分發(fā)的原料藥放行前 審核已完成的關(guān)鍵步驟的批生產(chǎn)記錄和實(shí)驗(yàn)室控制記錄 Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution 4 確保已經(jīng)對重大的偏差進(jìn)行了調(diào)查 并已解決 Making sure that critical deviations are investigated and resolved 5 批準(zhǔn)所有的規(guī)格標(biāo)準(zhǔn)和主生產(chǎn)規(guī)程 Approving all specifications and master production instructions 6 批準(zhǔn)所有可能影響原料藥或中間體質(zhì)量的程序 Approving all procedures affecting the quality of intermediates or APIs 7 確保進(jìn)行內(nèi)部審計(jì) 自查 Making sure that internal audits self inspections are performed 8 批準(zhǔn)中間體和原料藥的委托生產(chǎn)商 Approving intermediate and API contract manufacturers 9 批準(zhǔn)可能影響到中間體或原料藥質(zhì)量的變更 Approving changes that potentially affect intermediate or API quality 10 審核并批準(zhǔn)驗(yàn)證方案和報(bào)告 Reviewing and approving validation protocols and reports 11 確保調(diào)查并解決質(zhì)量問題的投訴 Making sure that quality related complaints are investigated and resolved 精品文檔 11歡迎下載 12 確保用有效的體系來維修和校驗(yàn)關(guān)鍵設(shè)備 Making sure that effective systems are used for maintaining and calibrating critical equipment 表 1 1 本指南在原料藥生產(chǎn)中的應(yīng)用 4 TableTable 1 1 ApplicationApplication ofof thisthis GuidanceGuidance toto APIAPI ManufacturingManufacturing 生 產(chǎn) 類 型 TypeType ofof ManufacturingManufacturing 本指南在用于各類生產(chǎn)的工藝步驟 灰色背景 中的應(yīng)用 ApplicationApplication ofof thisthis guidanceguidance toto stepssteps shown shown inin gray gray usedused inin thisthis typetype ofof manufacturingmanufacturing 化學(xué)品的生產(chǎn) Chemical Manufacturing 原料藥起始物料 的生產(chǎn) Production of the API starting material 原料藥起始物料引 入工藝過程 Introduction of the API starting material into process 中間體的生產(chǎn) Production of Intermediate s 分離和精制 Isolation and purification 物理加工和包 裝 Physical processing and packaging 從動物源得到的原 料藥 API derived from animal sources 器官 分泌物或 組織的收集 Collection of organ fluid or tissue 切割 混合和 或初 步加工 Cutting mixing and or initial processing 原料藥起始物料引入 工藝過程 Introduction of the API starting material into process 分離和精制 Isolation and purification 物理加工和包 裝 Physical processing and packaging 從植物源提取的原 料藥 API extracted from plant sources 植物的收集 Collection of plant 切割和初步提取 Cutting and initial extraction s 原料藥起始物料引入 工藝過程 Introduction of the API starting material into process 分離和精制 Isolation and purification 物理加工和包 裝 Physical processing and packaging 草藥提取物用作原 料藥 Herbal extracts used as API 植物的收集 Collection of plants 切割和初步提取 Cutting and initial extraction 進(jìn)一步提取 Further extraction 物理加工和包 裝 Physical processing and packaging 由粉碎的或粉末狀 藥草組成的原料藥 API consisting of comminuted or powdered herbs 植物的收集和 或 培養(yǎng)和收獲 Collection of plants and or cultivation and harvesting 切割 粉碎 Cutting comminuting 物理加工和包 裝 Physical processing and packaging 生物技術(shù) 發(fā)酵 細(xì) 胞培養(yǎng) Biotechnology Fermentation cell culture 主細(xì)胞庫和工作 細(xì)胞庫的建立 Establishment of master cell bank and working cell bank 工作細(xì)胞庫的維護(hù) Maintenance of working cell bank 細(xì)胞培養(yǎng)和 或發(fā)酵 Cell culture and or fermentation 分離和精制 Isolation and purification 物理加工和包 裝 Physical processing and packaging 精品文檔 12歡迎下載 經(jīng)典 發(fā)酵生產(chǎn)原 料藥 Classical Fermentation to produce an API 細(xì)胞庫的建立 Establishment of cell bank 細(xì)胞庫的維護(hù) Maintenance of the cell bank 細(xì)胞引入發(fā)酵 Introduc