【正文】 ve systems are used for maintaining and calibrating critical equipment13. Making sure that materials are appropriately tested and the results are reported14. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate15. Performing product quality reviews (as defined in Section ) 獨立的質(zhì)量部門的主要職責不應(yīng)當委派給他人。用于生產(chǎn)商控制范圍以外的中間體的放行與否；2. 建立一個放行與拒收原材料、中間體、包裝材料和標簽的系統(tǒng)；3. 在供銷售的原料藥放行前，審核已完成的關(guān)鍵步驟的批生產(chǎn)記錄和實驗室檢驗記錄；4. 確保已對重大偏差進行了調(diào)查并已解決；5. 批準所有的規(guī)格標準和主生產(chǎn)指令；6. 批準所有可能影響原料藥和中間體質(zhì)量的規(guī)程；7. 確保進行內(nèi)部審計（自檢）；8. 批準中間體或原料藥的委托生產(chǎn)商；9. 批準可能影響到中間體或原料藥質(zhì)量的變更；10. 審核并批準驗證方案和報告；11. 確保調(diào)查并解決質(zhì)量問題的投訴；12. 確保用有效的體系來維護和校驗關(guān)鍵設(shè)備；13. 確保物料都經(jīng)過了適當?shù)臋z驗并報告結(jié)果；14. 確保有穩(wěn)定性數(shù)據(jù)支持中間體或原料藥的復驗期或有效期和儲存條件；15. 開展產(chǎn)品質(zhì)量審核（）。 Internal Audits (Self Inspection)（自檢） To verify pliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule. 為確實符合原料藥GMP原則，應(yīng)當按照批準的計劃進行定期的內(nèi)部審計。獲準的整改措施應(yīng)當及時、有效地完成。此種審核通常應(yīng)當每年進行一次，并記錄，內(nèi)容至少應(yīng)當包括：● 關(guān)鍵工藝控制以及原料藥關(guān)鍵測試結(jié)果的審核；● 所有不符合既定質(zhì)量標準的產(chǎn)品批號的審核；● 所有關(guān)鍵的偏差或違規(guī)行為及有關(guān)調(diào)查的審核；● 任何工藝或分析方法變動的審核；● 穩(wěn)定性監(jiān)測的審核；● 所有與質(zhì)量有關(guān)的退貨、投訴和召回的審核；● 整改措施的適當性的審核。此類整改措施的理由應(yīng)當文件化。3. PERSONNEL3. 人員 Personnel Qualifications There should be an adequate number of personnel qualified by appropriate education, training, and/or experience to perform and supervise the manufacture of intermediates and APIs. 應(yīng)當有足夠數(shù)量的員工具備從事和監(jiān)管原料藥和中間體生產(chǎn)的教育、培訓和/或經(jīng)歷等資格。 Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee’s functions. Records of training should be maintained. Training should be periodically assessed. 應(yīng)當由有資格的人員定期進行培訓，內(nèi)容至少應(yīng)當包括員工所從事的特定操作和與其職能有關(guān)的GMP。 Personnel Hygiene 員工的衛(wèi)生 Personnel should practice good sanitation and health habits. 員工應(yīng)當養(yǎng)成良好的衛(wèi)生和健康習慣。其它保護性用品如頭、臉、手和臂等遮護用品必要時也應(yīng)當佩帶，以免原料藥和中間體受到污染。 Smoking, eating, drinking, chewing and the storage of food should be restricted to certain designated areas separate from the manufacturing areas. 吸煙、吃、喝、咀嚼及存放食品僅限于與生產(chǎn)區(qū)隔開的指定區(qū)域。在任何時候（經(jīng)醫(yī)學檢驗或監(jiān)控檢查）任何患有危及到原料藥質(zhì)量的疾病或創(chuàng)傷的人員都不應(yīng)當參與作業(yè)，直到健康狀況已恢復，或者有資格的醫(yī)學人員確認該員工不會危及到原料藥的安全性和質(zhì)量。 Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants. 顧問的姓名、地址、資格和提供服務(wù)的類型都應(yīng)當有文字記錄。設(shè)施的設(shè)計應(yīng)盡量減少潛在的污染。 Buildings and facilities should have adequate space for the orderly placement of equipment and materials to prevent mixups and contamination. 廠房和設(shè)施應(yīng)有足夠空間，以便有秩序地放置設(shè)備和物料，防止混淆和污染。 The flow of materials and personnel through the building or facilities should be designed to prevent mixups and contamination. 通過廠房和設(shè)施的物流和人流的設(shè)計應(yīng)當能防止混雜和污染。 Adequate and clean washing and toilet facilities should be provided for personnel. These facilities should be equipped with hot and cold water, as appropriate, soap or detergent, air dryers, or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate. 應(yīng)當為員工提供足夠和清潔的盥洗設(shè)施。盥洗室應(yīng)當與生產(chǎn)區(qū)隔離，但要便于達到。 Laboratory areas/operations should normally be separated from production areas. Some laboratory areas, in particular those used for inprocess controls, can be located in production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements, and the laboratory and its operations do not adversely affect the production process, intermediate, or API. 實驗室區(qū)域/操作通常應(yīng)當與生產(chǎn)區(qū)隔離。 Utilities 公用設(shè)施 All utilities that could affect product quality (., steam, gas, pressed air, heating, ventilation, and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded. Drawings for these utility systems should be available. 對產(chǎn)品質(zhì)量會有影響的所有公用設(shè)施（如蒸汽，氣體，壓縮空氣和加熱，通風及空調(diào)）都應(yīng)當確認合格，并進行適當監(jiān)控，在超出限度時應(yīng)當采取相應(yīng)措施。 Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. These systems should be designed and constructed to minimize risks of contamination and crosscontamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate to the stage of manufacture. Particular attention should be giving to areas where APIs are exposed to the environment. 應(yīng)當根據(jù)情況，提供足夠的通風、空氣過濾和排氣系統(tǒng)。特別值得注意的是原料藥暴露的區(qū)域。 Permanently installed pipework should be appropriately identified. This can be acplished by identifying individual lines, documentation, puter control system, or alternative means. Pipework should be located to avoid risks of contamination of the intermediate or ApI. 永久性安裝的管道應(yīng)當有適宜的標識。管道的安裝處應(yīng)當防止污染中間體或原料藥。 Water 水 Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use. 原料藥生產(chǎn)中使用的水應(yīng)當證明適合于其預定的用途。 If drinking (portable) water is insufficient to ensure API quality and tighter chemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms, and/or endotoxins should be established. 如果飲用水不足以確保原料的質(zhì)量，并要求更為嚴格的化學和/或微生物水質(zhì)規(guī)格標準，應(yīng)當指定合適的物理/化學特性、微生物總數(shù)、控制菌和/或內(nèi)毒素的規(guī)格標準。 Where the manufacturer of a nonsterile API either intends or claims that it is suitable for use in further processing to produce a sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins. 當非無菌原料藥的制造商打算或者聲稱該原料藥適用于進一步加工生產(chǎn)無菌藥品（醫(yī)療用品）時，最終分離和精制階段的用水應(yīng)當進行微生物總數(shù)、致病菌和內(nèi)毒素方面的監(jiān)測和控制。 The use of dedicated production areas should also be considered when material of an infectious nature or high pharm