【文章內(nèi)容簡(jiǎn)介】 理PERSONNEL ORGANISATION 通則General Requirements 人事處應(yīng)為各部門配備足夠數(shù)量的勝任相應(yīng)工作能力、培訓(xùn)、經(jīng)驗(yàn)、專業(yè)技術(shù)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(jī)構(gòu)圖，明確各負(fù)責(zé)人職責(zé)權(quán)限。質(zhì)量相關(guān)的工作職責(zé)不應(yīng)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(fù)責(zé)生產(chǎn)、質(zhì)保、銷售、產(chǎn)品出廠環(huán)節(jié)的工作人員為關(guān)鍵人員。負(fù)責(zé)生產(chǎn)和質(zhì)保的人員不能兼任，但均有責(zé)任實(shí)現(xiàn)質(zhì)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(fù)責(zé)監(jiān)督生產(chǎn)和質(zhì)量的關(guān)鍵人員應(yīng)具備化學(xué)、藥劑學(xué)、化學(xué)工藝、微生物等學(xué)科工藝培訓(xùn)經(jīng)歷及法規(guī)要求的操作經(jīng)驗(yàn)等資質(zhì)。從事新工作項(xiàng)時(shí)應(yīng)遵循專業(yè)人員指導(dǎo)。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(guān)鍵人員除生產(chǎn)關(guān)系外禁止利益往來(lái)或沖突以便執(zhí)行指定的職責(zé)。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(wèn)禁止從事關(guān)鍵崗位操作。Persons engaged parttime or in consultative capacity should not be appointed to key positions. 關(guān)鍵崗位職能可以委托，但是職責(zé)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(zé)Key Responsibilities 明確定義關(guān)鍵人員職責(zé)并依據(jù)指導(dǎo)方針和相關(guān)法律法規(guī)進(jìn)行委派。Responsibilities of key personnel should be clearly defined and allocated in accordance with these guidelines and national legislation. 生產(chǎn)部門職責(zé)：The production department has the following responsibilities:（1） 根據(jù)書(shū)面程序起草、審核、批準(zhǔn)并下發(fā)原料藥生產(chǎn)指令單，根據(jù)預(yù)先批準(zhǔn)的指令生產(chǎn)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(chǎn)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(chǎn)品偏差的及時(shí)上報(bào)及評(píng)估，調(diào)查關(guān)鍵偏差并記錄結(jié)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(chǎn)設(shè)施清潔和定期消毒。Making sure that production facilities are clean and when appropriate disinfected.（5） 確保校驗(yàn)的執(zhí)行及記錄存檔。Making sure that the necessary calibrations are performed and records kept.（6） 確保廠房和設(shè)備的維護(hù)保養(yǎng)及相關(guān)記錄存檔。Making sure that the premises and equipment are maintained and records kept.（7） 確保驗(yàn)證方案及報(bào)告經(jīng)審核并獲得批準(zhǔn)。Making sure that validation protocols and reports are reviewed and approved.（8） 提出產(chǎn)品、工藝或設(shè)備變更。Evaluating proposed changes in product, process or equipment.（9） 確保設(shè)備設(shè)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(zé)見(jiàn)本手冊(cè)相關(guān)章節(jié)要求。Other duties are given in the relevant section of this manual. 質(zhì)量部門有權(quán)參與質(zhì)量相關(guān)全部事宜，其主要職責(zé)不予委派且包括但不僅限以下項(xiàng)：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(biāo)簽的放行或拒收系統(tǒng)。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(chǎn)品生產(chǎn)和關(guān)鍵步驟檢測(cè)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(diào)查及關(guān)閉。Making sure that critical deviations are investigated and resolved. （5）審批質(zhì)量標(biāo)準(zhǔn)和生產(chǎn)指令。Approving all specifications and production instructions.（6）審批影響原料藥質(zhì)量的流程，執(zhí)行相關(guān)監(jiān)管流程。包括內(nèi)審（自檢） 、委托生產(chǎn)、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(zhǔn)驗(yàn)證方案及報(bào)告。Reviewing and approving validation protocols and reports.（8）確保質(zhì)量相關(guān)投訴經(jīng)調(diào)查解決。Making sure that quality related plaints are investigated and resolved.（10）確保關(guān)鍵設(shè)備維護(hù)、校正有效運(yùn)行。Making sure that effective systems are used for maintaining and calibrating critical equipment.（11）確保原輔料正確檢測(cè)并出具報(bào)告。Making sure that materials are appropriately tested and the results are reported.（12）確保原料藥有效期和倉(cāng)儲(chǔ)條件有穩(wěn)定性數(shù)據(jù)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(zhí)行產(chǎn)品質(zhì)量回顧。Performing product quality reviews.其他職責(zé)參見(jiàn)本手冊(cè)相關(guān)章節(jié)。Other duties are given in the relevant sections of this Manual. 廠長(zhǎng)同樣對(duì)質(zhì)量負(fù)責(zé)，在遵守相關(guān)法規(guī)要求條件下具備下列職責(zé)：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(zhǔn)。The authorization of written procedures and other documents including amendments（2）生產(chǎn)環(huán)境的監(jiān)督和控制。15 / 106The monitoring and control of the manufacturing environment（2） 廠區(qū)衛(wèi)生Plant hygiene（3） 工藝驗(yàn)證Process validation（4） 培訓(xùn)Training（5） 物料供應(yīng)商、委托生產(chǎn)的批準(zhǔn)和監(jiān)管。The approval and monitoring of suppliers of materialsThe approval and monitoring of contract manufacturers（6） 監(jiān)管物料和成品的貯