【正文】 able to the facilities provided。操作方法與規(guī)程應(yīng)當(dāng)使用有指導(dǎo)意義的方式來(lái)書寫，并且條理清楚、用語(yǔ)明確 ，特別是要適用于相應(yīng)的設(shè)施 ；v. operators are trained to carry out procedures correctly。 操作人員接受過(guò)正確執(zhí)行規(guī)程的培訓(xùn)；vi. records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated。 在生產(chǎn)過(guò)程中進(jìn)行了記錄，可由手工和/ 或儀器記錄，以證明規(guī)程和操作要求的所有步驟切實(shí)得到了執(zhí)行，以及產(chǎn)品的質(zhì)量和數(shù)量達(dá)到預(yù)期要求；所有重大偏差得到了完整記錄、經(jīng)過(guò)了調(diào)查vii. records of manufacture including distribution which enable the plete history of a batch to be traced, are retained in a prehensible and accessible form。生產(chǎn)記錄包括銷售記錄以易懂且可獲得的方式得到了保留，使整個(gè)批次的完整歷史可追溯；viii. the distribution (wholesaling) of the products minimises any risk to their quality。降低產(chǎn)品銷售過(guò)程中的質(zhì)量風(fēng)險(xiǎn)；ix. a system is available to recall any batch of product, from sale or supply。有藥品召回系統(tǒng)，確保任何一批產(chǎn)品都能從銷售商或供應(yīng)處收回；x. plaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.對(duì)產(chǎn)品投訴進(jìn)行檢查，調(diào)查質(zhì)量缺陷原因，對(duì)缺陷產(chǎn)品采取適當(dāng)措施并防止再次發(fā)生。QUALITY CONTROL 質(zhì)量控制 Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The basic requirements of Quality Control are that:質(zhì)量 控 制 是 G M P 的一部分，涉及取樣、質(zhì)量標(biāo)準(zhǔn)、檢驗(yàn)，同樣也涉及組織機(jī)構(gòu)、文件和放行規(guī)程，以保證切實(shí)執(zhí)行了必要的相關(guān)檢驗(yàn)，并且確保物料或產(chǎn)品被判定符合要求之前不被放行使用或銷售。質(zhì)量控制的基本要求是：i. adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes。有 充足 的設(shè)施設(shè) 備、經(jīng)過(guò)培訓(xùn)的人員及經(jīng)過(guò)批準(zhǔn)的規(guī)程用于起始物料、包 裝 材 料 、中間體、半成品與成品取樣和檢驗(yàn)，以及 G M P 要 求 的 環(huán) 境 監(jiān) 測(cè)ii. samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control。由經(jīng)過(guò)批準(zhǔn)的人員按經(jīng)過(guò)批準(zhǔn)的方法對(duì)起始物料、包裝材料、中間產(chǎn)品、半成品、成 品 取 樣 ；iii. test methods are validated。 檢 驗(yàn) 方法 經(jīng)過(guò) 驗(yàn) 證 ；iv. records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated。由手工和/ 或儀器做了記錄，以證明所有要求的取樣、檢查和檢驗(yàn)規(guī)程切實(shí)得到了執(zhí)行。任何偏差得到了完整記錄和調(diào)查；v. the finished products contain active ingredients plying with the qualitative and quantitative position of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled。成品中的活性成分符合上市許可或臨床試驗(yàn)許可的定性和定量要求，及符合純度要求，并貯 存在適當(dāng)?shù)娜萜髦小①N 上 正 確 的 標(biāo) 簽 ；vi. records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures。物料 、中間體、半成品及成品的檢查與檢驗(yàn)結(jié)果有記錄，成品按質(zhì)量標(biāo)準(zhǔn)做了正式評(píng)估。產(chǎn)品評(píng)估包括回顧與評(píng)估相關(guān)生產(chǎn)文件，以及評(píng)估對(duì)特定規(guī)程的偏差；vii. no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the relevant authorisations。在質(zhì)量受權(quán)人確認(rèn)產(chǎn)品批次符合相應(yīng)許可要求之前，任何批次不被放行銷售或供貨；viii. sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.留有足夠的起始物料和成品對(duì)照樣品， 以備將來(lái)有需要的時(shí)候?qū)Ξa(chǎn)品進(jìn)行檢驗(yàn)，樣品包裝方式與對(duì)應(yīng)的產(chǎn)品最終包裝方式相同。PRODUCT QUALITY REVIEW產(chǎn)品質(zhì)量回顧 Regular periodic or rolling quality reviews of all licensed medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:應(yīng)當(dāng)對(duì)所有獲得批準(zhǔn)的藥品，包括僅供出口的藥品，進(jìn)行定期的或滾動(dòng)式的質(zhì)量回顧，質(zhì)量回顧的目的是確認(rèn)現(xiàn)有工藝的一致性、起始物料和成品現(xiàn)行質(zhì)量標(biāo)準(zhǔn)的適宜性，強(qiáng)調(diào)任何趨勢(shì)并識(shí)別產(chǎn)品和工藝改進(jìn)點(diǎn)。通常應(yīng)當(dāng)每年回顧并文件化，回顧中還應(yīng)當(dāng)考慮以前的回顧情況，并至少應(yīng)當(dāng)包括：i. A review of starting materials including packaging materials used in the product, especially those from new sources.回顧產(chǎn)品所用起始物料、包裝材料，特別是來(lái)自新供應(yīng)商的起始物料和包裝材料，ii. A review of critical inprocess controls and finished product results. 回顧關(guān)鍵中間過(guò)程控制與成品結(jié)果。iii. A review of all batches that failed to meet established specification(s) and their investigation.回顧未能符合既定質(zhì)量標(biāo)準(zhǔn)的所有批次及其調(diào)查結(jié)果。iv. A review of all significant deviations or nonconformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken.回顧所有重大偏差或不符合事件與相關(guān)調(diào)查，以及后續(xù)糾正與預(yù)防措施的有效性。v. A review of all changes carried out to the processes or analytical methods.回顧工藝或分析方法的所有變更。vi. A review of Marketing Authorisation variations submitted/granted/refused, including those for third country (export only) dossiers.回顧已遞交的、 已批準(zhǔn)的或被拒絕的上市許可變更，包括已遞交的、 已批準(zhǔn)的或被拒絕的第三 國(guó) （ 僅供出口）上市許可變更資料。vii. A review of the results of the stability monitoring programme and any adverse trends.回顧穩(wěn)定性監(jiān)測(cè)程序的結(jié)果以及任何不良的趨勢(shì)。viii. A review of all qualityrelated returns, plaints and recalls and the investigations performed at the time.回顧與質(zhì)量相關(guān)的所有退貨、投訴與召回，以及當(dāng)時(shí)實(shí)施的調(diào)查。ix. A review of adequacy of any other previous product process or equipment corrective actions.回顧任何其他先前產(chǎn)品工藝或設(shè)備糾正措施的適宜性。x. For new marketing authorisations and variations to marketing authorisations, a review of postmarke