5.1 設計與建造（Design and Construction）
5.10 中間產物及原料藥之製造設備，應有適 當的設計及足夠的大小，並安裝在適當 的位置，以適合預定用途、清潔、合適 時之減菌處理及維護保養。
5.10 Equipment used in the manufacture of intermediates and APIs should be of appropriate design and adequate size, and suitably located for its intended use, cleaning, sanitization (where
appropriate), and maintenance.
5.11 設備應適當建造，以使其接觸原料、中 間產物或原料藥的表面，不會改變中間 產物及原料藥的品質超出法定或其他 既定規格。
5.11 Equipment should be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications.
5.12 生產設備應只在其驗證過的作業範圍 內使用。
5.12 Production equipment should only be used within its qualified operating range.
5.13 在中間產物或原料藥之生產中使用的 主要設備（例如，反應器、儲存容器）
及永久性安裝的作業線，應適當地識 別。
5.13 Major equipment (e.g., reactors, storage containers) and permanently installed processing lines used during the production of an intermediate or API should be appropriately identified.
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5.14 與設備之操作關聯的任何物質，例如，
潤滑劑、熱媒或冷媒，不得接觸中間產 物或原料藥，以免導致其品質改變而超 出法定或其他既定規格。有異於此之任 何偏差，應加以評估，以確保其對該中 間產物或原料藥之預定用途的適用性 無有害的影響。可能時，應使用食品級 的潤滑劑及油品。
5.14 Any substances associated with the operation of equipment, such as lubricants, heating fluids or coolants, should not contact intermediates or APIs so as to alter their quality beyond the official or other established
specifications. Any deviations from this should be evaluated to ensure that there are no detrimental effects upon the fitness for purpose of the material.
Wherever possible, food grade lubricants and oils should be used.
5.15 合適時，應使用密閉性或圍堵性的設 備。當使用開放性的設備，或設備打開 時，應採取適當的防範措施，以使污染 的風險降到最低。
5.15 Closed or contained equipment should be used whenever appropriate. Where open equipment is used, or equipment is opened, appropriate precautions should be taken to minimize the risk of
contamination.
5.16 設備及關鍵的裝置（例如，儀表裝置及 公用設施系統），應保存一套其最新的 建構圖。
5.16 A set of current drawings should be maintained for equipment and critical installations (e.g., instrumentation and utility systems).
5.2 設備維護保養及清潔（Equipment Maintenance and Cleaning）
5.20 應建立設備之預防性維護保養的時程 表及程序（包含責任的指派）。
5.20 Schedules and procedures (including assignment of responsibility) should be established for the preventative
maintenance of equipment.
5.21 設備之清潔及其隨後放行供中間產物 及原料藥之製造使用，應建立書面程 序。清潔程序應包含充分的細節，以使 操作者能以可再現且有效的方式清潔 每一型式的設備。這些程序應包括：
5.21 Written procedures should be established for cleaning of equipment and its
subsequent release for use in the
manufacture of intermediates and APIs.
Cleaning procedures should contain sufficient details to enable operators to clean each type of equipment in a reproducible and effective manner.
These procedures should include:
設備之清潔責任的指派； Assignment of responsibility for cleaning of equipment;
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清潔時程，合適時，包含減菌處理 時程表；
Cleaning schedules, including, where appropriate, sanitizing schedules;
清潔方法及材料之完整說明，包含 清潔設備使用之清潔劑的稀釋方 法；
A complete description of the methods and materials, including dilution of cleaning agents used to clean equipment;
合適時，拆解及組裝設備之每一物 件的指令，以確保正確之清潔；
When appropriate, instructions for disassembling and reassembling each article of equipment to ensure proper cleaning;
先前批次標識之移除或塗消的指 令；
Instructions for the removal or obliteration of previous batch identification;
保護潔淨設備在使用前免於污染 的指令；
Instructions for the protection of clean equipment from
contamination prior to use;
可行時，使用前檢查設備之潔淨 度；以及
Inspection of equipment for
cleanliness immediately before use, if practical; and
合適時，建立在作業完成後與設備 清潔前最長的時間間隔。
Establishing the maximum time that may elapse between the completion of processing and equipment cleaning, when appropriate.
5.22 設備及器具應予清潔、儲存，以及可行 時，減菌處理或滅菌，以防止污染或殘 留物的移轉，導致改變中間產物或原料 藥的品質超出法定或既定之規格。
5.22 Equipment and utensils should be cleaned, stored, and, where appropriate, sanitized or sterilized to prevent
contamination or carry-over of a material that would alter the quality of the
intermediate or API beyond the official or other established specifications.
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5.23 當設備用於連續或時段切換生產同一 中間產物或原料藥時，設備應在適當間 隔時間予以清潔，以防止污染物的積集 及移轉（例如，分解產物或過量的微生 物）。
5.23 Where equipment is assigned to continuous production or campaign production of successive batches of the same intermediate or API, equipment should be cleaned at appropriate intervals to prevent build-up and carry-over of contaminants (e.g., degradants or objectionable levels of microorganisms).
5.24 非專用設備在不同物質的生產間應加 以清潔，以防止交叉污染。
5.24 Non-dedicated equipment should be cleaned between productions of different materials to prevent
cross-contamination.
5.25 殘留物之允收標準及清潔程序與清潔 劑的選擇，應予界定並證明其合理。
5.25 Acceptance criteria for residues and the choice of cleaning procedures and cleaning agents should be defined and justified.
5.26 設備之內容物及其潔淨度狀態應以適 當方法予以識別。
5.26 Equipment should be identified as to its contents and its cleanliness status by appropriate means.
5.3 校正（Calibration）
5.30 為確保中間產物或原料藥品質，其關鍵 性之管制、秤重、量測、監測，以及測 試的設備，應依書面程序及既定時程表 予以校正。
5.30 Control, weighing, measuring, monitoring and test equipment that is critical for assuring the quality of intermediates or APIs should be calibrated according to written
procedures and an established schedule.
5.31 如有可追溯到公認標準的標準件，則應 使用該標準件執行設備校正。
5.31 Equipment calibrations should be performed using standards traceable to certified standards, if existing.
5.32 校正紀錄應予保存。 5.32 Records of these calibrations should be maintained.
5.33 應知悉關鍵設備之最近校正狀態並可 證實。
5.33 The current calibration status of critical equipment should be known and
verifiable.
5.34 不得使用未符合校正標準的儀器。 5.34 Instruments that do not meet calibration criteria should not be used.
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5.35 關鍵儀器之校正結果與核可標準有偏 差時，應予調查，以認定自最後一次成 功校正後是否對中間產物或原料藥的 品質造成影響。
5.35 Deviations from approved standards of calibration on critical instruments should be investigated to determine if these could have had an impact on the quality of the intermediate(s) or API(s)
manufactured using this equipment since the last successful calibration.
5.4 電腦化系統（Computerized Systems）
5.40 與 GMP 有關的電腦化系統應予確效。
確效的深度與範圍依該電腦化應用之 多樣性、複雜性以及關鍵性而定。
5.40 GMP-related computerized systems should be validated. The depth and scope of validation depends on the diversity, complexity, and criticality of the computerized application.
5.41 適當的安裝驗證及操作驗證應證明電 腦硬體及軟體的適當性，以執行指定的 工作。
5.41 Appropriate installation qualification and operational qualification should
demonstrate the suitability of computer hardware and software to perform assigned tasks.
5.42 經驗證之市售套裝軟體不要求相同程 度的測試。現有系統在安裝時未經確效 者，如有適當文件憑證，則可執行回溯 性確效。
5.42 Commercially available software that has been qualified does not require the same level of testing. If an existing system was not validated at time of installation, a retrospective validation could be conducted if appropriate documentation is available.
5.43 電腦化系統應有充分之管制，以防止未 經授權的侵入或對資料的變更。應有防 止資料遺漏（例如，系統中斷及資料漏 載）的管制。進行任何資料的變更、先 前的輸入、誰進行變更，以及何時進行 變更應有紀錄。
5.43 Computerized systems should have sufficient controls to prevent
unauthorized access or changes to data.
There should be controls to prevent omissions in data (e.g., system turned off and data not captured). There should be a record of any data change made, the previous entry, who made the change, and when the change was made.
5.44 電腦化系統之操作及維護保養應有書 面程序。
5.44 Written procedures should be available for the operation and maintenance of computerized systems.
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5.45 在以手工輸入關鍵資料時，對該輸入之 準確性應有額外的核對。這可由第二位 操作者或由系統本身達成。
5.45 Where critical data are being entered manually, there should be an additional check on the accuracy of the entry. This can be done by a second operator or by the system itself.
5.46 與可能影響中間產物或原料藥之品 質、紀錄或試驗結果之可靠性的電腦化 系統有關之意外事件，應予記錄與調 查。
5.46 Incidents related to computerized systems that could affect the quality of intermediates or APIs or the reliability of records or test results should be recorded and investigated.
5.47 電腦化系統之變更，應依變更程序為 之，且應經正式授權、文件化及測試。
含對硬體、軟體以及該系統之其他關鍵 組件，有修改及升級之所有變更者，其 記錄均應予保存。這些紀錄應證明該系 統是維持在確效狀態中。
5.47 Changes to computerized systems should be made according to a change
procedure and should be formally authorized, documented, and tested.
Records should be kept of all changes, including modifications and
enhancements made to the hardware, software, and any other critical
component of the system. These records should demonstrate that the system is maintained in a validated state.
5.48 系統當機或失效會導致紀錄之永久喪 失者，應有備用系統。對於所有電腦化 系統皆應建立確保資料的方法。
5.48 If system breakdowns or failures would result in the permanent loss of records, a back-up system should be provided. A means of ensuring data protection should be established for all computerized systems.
5.49 除電腦系統外，資料得以第二種方法記 錄之。
5.49 Data can be recorded by a second means in addition to the computer system.