【正文】 Containment 限制 Dedicated production areas, which can include facilities, air handling equipment and/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosprins. 在高致敏性物質(zhì)，如青霉素或頭孢菌素類的生產(chǎn)中，應(yīng)當(dāng)使用專用的生產(chǎn)區(qū)，包括設(shè)施、空氣處理設(shè)備和/或工藝設(shè)備。 Where water used in the process is treated by the manufacturer to achieve a defined quality, the treatment process should be validated and monitored with appropriate action limits. 在工藝用水為達(dá)到規(guī)定質(zhì)量由制造商進(jìn)行處理時(shí)，處理工藝應(yīng)當(dāng)經(jīng)過驗(yàn)證，并用合適的處置限度來監(jiān)測(cè)。 Unless otherwise justified, process water should, at a minimum, meet World Health Organization (WHO) guidelines for drinking (portable) water quality. 除非有其它理由，工藝用水最低限度應(yīng)當(dāng)符合世界衛(wèi)生組織（WHO）的飲用水質(zhì)量指南。 Drains should be of adequate size and should be provided with an air break or a suitable device to prevent backsiphonage, when appropriate. 排水溝應(yīng)當(dāng)有足夠的尺寸，而且應(yīng)當(dāng)根據(jù)情況裝有空斷器或適當(dāng)?shù)难b置，防止倒虹吸。這可以通過標(biāo)識(shí)每根管道、提供證明文件、計(jì)算機(jī)控制系統(tǒng)，或其它替代方法來達(dá)到。 If air is recirculated to production areas, appropriate measures should be taken to control risks of contamination and crosscontamination. 如果空氣再循環(huán)到生產(chǎn)區(qū)域，應(yīng)當(dāng)采取適當(dāng)?shù)目刂莆廴竞徒徊嫖廴镜娘L(fēng)險(xiǎn)。這些系統(tǒng)應(yīng)當(dāng)根據(jù)相應(yīng)的生產(chǎn)階段，設(shè)計(jì)和建造成將污染和交叉污染降至最低限度，并包括控制氣壓、微生物（如果適用）、灰塵、濕度和溫度的設(shè)備。應(yīng)當(dāng)有這些公用設(shè)施的系統(tǒng)圖。有些實(shí)驗(yàn)室區(qū)域，特別是用于中間控制的，可以位于生產(chǎn)區(qū)內(nèi)，只要生產(chǎn)工藝操作對(duì)實(shí)驗(yàn)室測(cè)量的準(zhǔn)確性沒有負(fù)面影響，而且，實(shí)驗(yàn)室及其操作對(duì)生產(chǎn)過程，或中間體，或原料藥也沒有負(fù)面影響。應(yīng)當(dāng)根據(jù)情況提供足夠的淋浴和/或更衣設(shè)施。這些盥洗設(shè)施應(yīng)當(dāng)裝有冷熱水（視情況而定）、肥皂或洗滌劑，干手機(jī)和一次性毛巾。 There should be defined areas or other control systems for the following activities:● Receipt, identification, sampling, and quarantine of ining materials, pending release or rejection● Quarantine before release or rejection of intermediates and APIs● Sampling of intermediates and APIs● Holding rejected materials before further disposition (., return, reprocessing or destruction)● Storage of released materials● Production operations● Packaging and labeling operations● Laboratory operations 以下活動(dòng)應(yīng)當(dāng)有指定區(qū)域或其它控制系統(tǒng)：● 來料的接收、鑒別、取樣和待驗(yàn)，等待放行或拒收；● 中間體和原料藥放行或拒收前的待驗(yàn)；● 中間體和原料藥的取樣● 不合格物料處理（如退貨、返工或銷毀）前的貯存；● 已放行物料的貯存；● 生產(chǎn)操作；● 包裝及貼標(biāo)簽操作；● 實(shí)驗(yàn)室操作。 Where the equipment itself (., closed or contained system) provides adequate protection of the material, such equipment can be located outdoors. 自身能對(duì)物料提供足夠保護(hù)的設(shè)備（如關(guān)閉的或封閉的系統(tǒng)），可以在戶外放置。如果中間體或原料藥的生產(chǎn)有微生物限度要求，那么設(shè)施設(shè)計(jì)應(yīng)相應(yīng)的限制有害微生物的污染。4. BUILDINGS AND FACILITIES4. 建筑和設(shè)施 Design and Construction 設(shè)計(jì)和結(jié)構(gòu) Buildings and facilities used in the manufacture of intermediates and APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the intermediate or API, facilities should also be designed to limit exposure to objectionable microbiological contaminants, as appropriate. 用于中間體和原料藥生產(chǎn)的廠房和設(shè)施的選址、設(shè)計(jì)和建造應(yīng)當(dāng)便于清潔，維護(hù)和適應(yīng)一定類型和階段的生產(chǎn)操作。 Consultants 顧問 Consultants advising on the manufacture and control of intermediates or APIs should have sufficient education, training, and experience, or any bination thereof, to advise on the subject for which they are retained. 中間體或原料藥生產(chǎn)和控制的顧問應(yīng)當(dāng)有足夠的學(xué)歷，受訓(xùn)和經(jīng)驗(yàn)，能勝任所承擔(dān)的工作。 Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in promising the quality of APIs. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the condition could adversely affect the quality of the APIs until the condition is corrected or qualified medical personnel determine that the person’s inclusion would not jeopardize the safety or quality of the APIs. 患傳染性疾病或身體表面有開放性創(chuàng)傷的員工不應(yīng)當(dāng)從事危及原料藥質(zhì)量的生產(chǎn)活動(dòng)。 Personnel should avoid direct contact with intermediates and APIs. 員工應(yīng)當(dāng)避免與中間體或原料藥的直接接觸。 Personnel should wear clean clothing suitable for the manufacturing activity with which they are involved and this clothing should be changed, when appropriate. Additional protective apparel, such as head, face, hand, and arm coverings, should be worn, when necessary, to protect intermediates and APIs from contamination. 員工應(yīng)當(dāng)穿著適合其所從事生產(chǎn)操作的干凈服裝，必要時(shí)應(yīng)當(dāng)更換。培訓(xùn)記錄應(yīng)當(dāng)保存，并應(yīng)當(dāng)定期對(duì)培訓(xùn)進(jìn)行評(píng)估。 The responsibilities of all personnel engaged in the manufacture of intermediates and APIs should be specified in writing. 參與原料藥和中間體生產(chǎn)的所有人員的職責(zé)應(yīng)當(dāng)書面規(guī)定。獲準(zhǔn)的整改措施應(yīng)當(dāng)及時(shí)、有效地完成。 The results of this review should be evaluated and an assessment made of whether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be pleted in a timely and effective manner. 應(yīng)當(dāng)對(duì)質(zhì)量審核結(jié)果進(jìn)行評(píng)估，并做出是否需要整改或做任何再驗(yàn)證的評(píng)價(jià)。 Product Quality Review Regular qualityreviews of APIs should be conducted with the objective of verifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:● A review of critical inprocess control and critical API test results● A review of all batches that failed to meet established specification(s)● A review of all critical deviations or nonconformances and related investigations● A review of any changes carried out to the processes or analytical methods● A review of results of the stability monitoring program● A review of all qualityrelated returns, plaints and recalls● A review of adequacy of corrective actions 原料藥的定期質(zhì)量審核應(yīng)當(dāng)以證實(shí)工藝的一致性為目的來進(jìn)行。 Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be pleted in a timely and effective manner. 審計(jì)結(jié)果及整改措施應(yīng)當(dāng)形成文件，并引起公司責(zé)任管理人員的重視。 Responsibility for Production ActivitiesThe responsibility for production activities should be described in writing and should include, but not necessarily be limited to:1. Preparing, reviewin