原料藥生產質量管理手冊doc(編輯修改稿)

　

【文章內容簡介】 理PERSONNEL ORGANISATION 通則General Requirements 人事處應為各部門配備足夠數量的勝任相應工作能力、培訓、經驗、專業技術資格和管理技能方面要求的員工。There should be sufficient number of personnel at all levels with the ability, training, experience and whatever necessary professional / technical qualifications and managerial skills appropriate to the tasks assigned to them. 建立組織機構圖，明確各負責人職責權限。質量相關的工作職責不應存在空缺或重疊。There should be an anization chart and all responsible persons should have their duties clarified and adequate authority to carry out their responsibilities. There should not be gaps or unexplained overlaps in the responsibilities of personnel concerned with GMP applications. 負責生產、質保、銷售、產品出廠環節的工作人員為關鍵人員。負責生產和質保的人員不能兼任，但均有責任實現質量要求。Key personnel include person responsible for production, person responsible for quality 12 / 106assurance and person responsible for sales/distribution. Different persons should be responsible for production and quality assurance, neither of who should be responsible for other, but who both have a responsibility for achieving the requisite quality. 負責監督生產和質量的關鍵人員應具備化學、藥劑學、化學工藝、微生物等學科工藝培訓經歷及法規要求的操作經驗等資質。從事新工作項時應遵循專業人員指導。The key personnel responsible for supervising the production and quality assurance should possess the qualification of scientific education and practical experience required for national legislation. This includes study of Chemistry, Pharmacy, Chemical Technology, Microbiology or other related gaining the practical experience, they should exercise their duties under professional guidance. 上述關鍵人員除生產關系外禁止利益往來或沖突以便執行指定的職責。Such key personnel should not have, preferably, any interests outside the manufacturer39。s anization so as to prevent or restrict their devoting the necessary time to their assigned duties and/or result into conflict of financial interest. 兼職人員或顧問禁止從事關鍵崗位操作。Persons engaged parttime or in consultative capacity should not be appointed to key positions. 關鍵崗位職能可以委托，但是職責不能委托。The duties of the key personnel may be delegated to the designated deputies with a satisfactory qualification. However, the responsibility cannot be delegated. 主要職責Key Responsibilities 明確定義關鍵人員職責并依據指導方針和相關法律法規進行委派。Responsibilities of key personnel should be clearly defined and allocated in accordance with these guidelines and national legislation. 生產部門職責：The production department has the following responsibilities:（1） 根據書面程序起草、審核、批準并下發原料藥生產指令單，根據預先批準的指令生產原料藥或中間體。Preparing, reviewing, approving and distributing the instructions for the production of APIs according to written APIs and, when appropriate, intermediates according to preapproved instructions.13 / 106（2） 審核所有批次產品記錄，確保已完成并簽字。Reviewing all production batch records and ensuring that these are pleted and signed.（3） 確保產品偏差的及時上報及評估，調查關鍵偏差并記錄結論。Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.（4） 確保生產設施清潔和定期消毒。Making sure that production facilities are clean and when appropriate disinfected.（5） 確保校驗的執行及記錄存檔。Making sure that the necessary calibrations are performed and records kept.（6） 確保廠房和設備的維護保養及相關記錄存檔。Making sure that the premises and equipment are maintained and records kept.（7） 確保驗證方案及報告經審核并獲得批準。Making sure that validation protocols and reports are reviewed and approved.（8） 提出產品、工藝或設備變更。Evaluating proposed changes in product, process or equipment.（9） 確保設備設施改造或新增符合要求。Making sure that new and, when appropriate, modified facilities and equipment are qualified.其他職責見本手冊相關章節要求。Other duties are given in the relevant section of this manual. 質量部門有權參與質量相關全部事宜，其主要職責不予委派且包括但不僅限以下項：The quality units should be involved in all quality related matters. 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） 原料藥放行或拒收。Releasing or rejecting all APIs.（2） 建立原料、中間體、包材及標簽的放行或拒收系統。Establishing a system to release or reject raw materials, intermediates, packaging and all labeling materials.（3）原料藥放行前審核完成的批產品生產和關鍵步驟檢測記錄。14 / 106Reviewing pleted batch production and laboratory control records of critical process steps before release of the API for distribution.（4）確保重大偏差的調查及關閉。Making sure that critical deviations are investigated and resolved. （5）審批質量標準和生產指令。Approving all specifications and production instructions.（6）審批影響原料藥質量的流程，執行相關監管流程。包括內審（自檢） 、委托生產、變更。Approving all procedures impacting the quality of making sure that Selfinspections、internal audits、contract manufacturers、changes are performed. （7）審核和批準驗證方案及報告。Reviewing and approving validation protocols and reports.（8）確保質量相關投訴經調查解決。Making sure that quality related plaints are investigated and resolved.（10）確保關鍵設備維護、校正有效運行。Making sure that effective systems are used for maintaining and calibrating critical equipment.（11）確保原輔料正確檢測并出具報告。Making sure that materials are appropriately tested and the results are reported.（12）確保原料藥有效期和倉儲條件有穩定性數據支持。Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs where appropriate, and（13）執行產品質量回顧。Performing product quality reviews.其他職責參見本手冊相關章節。Other duties are given in the relevant sections of this Manual. 廠長同樣對質量負責，在遵守相關法規要求條件下具備下列職責：The Heads of Plant and QA has some shared or jointly exercised responsibilities related to quality. These may include, with respect to national regulations。 （1） 文件及文件修正的批準。The authorization of written procedures and other documents including amendments（2）生產環境的監督和控制。15 / 106The monitoring and control of the manufacturing environment（2） 廠區衛生Plant hygiene（3） 工藝驗證Process validation（4） 培訓Training（5） 物料供應商、委托生產的批準和監管。The approval and monitoring of suppliers of materialsThe approval and monitoring of contract manufacturers（6） 監管物料和成品的貯