原則（PRINCIPLE）
藥品的正確製造仰賴於人。因此，藥廠 有責任配置足夠的合格人員。個別工作 人員應清楚瞭解其負責之工作並作成紀 錄。所有人員均應認知優良製造規範的 原則與其息息相關，並接受職前及持續 的訓練，包括與工作有關的衛生指導。
The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
一般規定（GENERAL）
2.1 藥廠應配置足夠人員，且具必要資格及
實務經驗。高層管理者應決定並提供充 足與適當的資源（人員、財務、物資、
設施及設備等）以執行及維持製藥品質 系統，且持續地改進其有效性。賦予每 一個人的責任不應過廣，以致對於品質 呈現任何風險。
2.1 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. Senior management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the
Pharmaceutical Quality System and continually improve its effectiveness.
The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
2.2 藥廠應有組織圖，其中，生產、品管主
管與合適時 2.5 條所提及之品質保證或 品質單位主管之間的關係，及被授權人 的位置，應清楚地顯示於其管理架構中。
2.2 The manufacturer must have an organisation chart in which the relationships between the heads of Production, Quality Control and where applicable Head of Quality Assurance or Quality Unit referred to in point 2.5 and the position of the Authorised Person(s) are clearly shown in the managerial
2.3 各職位的負責人應有書面工作說明記載 的特定職責，並經適當授權，以執行其 職責。其職責得委由足以勝任的指定代 理人行之。適用優良製造規範之有關人 員，其職責不應有漏洞或未經說明的重 疊。
2.3 People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.
2.4 高層管理者對於確保具備有效的製藥品
質系統以達成品質目標，以及人員之角 色與權責在整個組織中被界定、傳達與 執行，具有最終責任。高層管理者應建 立一個品質政策，描述公司與品質相關 之整體意圖與方向，並且應透過參與管 理審查，確保製藥品質系統與 GMP 循規 的持續適用性與有效性。
2.4 Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the
organisation. Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality and should ensure continuing suitability and effectiveness of the Pharmaceutical Quality System and GMP compliance through participation in management review.
關鍵人員（KEY PERSONNEL）
2.5 高層管理者應任命關鍵管理人員，包括 生產主管、品質管制主管，以及如果這 兩個人中至少有一位不負責產品之放行 時，為放行之目的所指定的被授權人。
重要的職位通常應由專職人員擔任。生 產和品質管制部門的主管應相互獨立。
大藥廠可能有必要委派人員，擔任 2.7、
2.8 及 2.9 條中所列之部分職務。另外，
根據公司之規模與組織架構，可指派個 別的品質保證主管或品質單位主管；若 該職務存在時，於 2.7、2.8 與 2.9 條中所 描述的職責，有部分是與品質管制主管 及生產主管分擔的，因此高層管理者應 謹慎界定其角色與權責。
2.5 Senior Management should appoint Key Management Personnel including the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the Authorised Person(s) designated for the purpose. Normally, key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2.7, 2.8 and 2.9. Additionally, depending on the size and organisational structure of the company, a separate Head of Quality Assurance or Head of the Quality Unit may be appointed. Where such a function exists usually some of the responsibilities described in 2.7, 2.8 and 2.9 are shared with the Head of Quality Control and Head of Production and senior management should therefore take care that roles, responsibilities, and authorities are defined.
2.6 被授權人之職責可歸納如下： 2.6 The duties of the Authorised Person(s) are described in the national
requirements and can be summarised as follows:
a) 被授權人必須確保每一批次藥品
已遵循國家有效法律及依照上市 許可的要求進行製造與檢查；
a) An Authorised Person must ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorisation;
b) 被授權人必須符合法規的資格要 求，他們須在製造許可持有者指派 下持續地履行其職責；
b) The Authorised Person(s) must meet the qualification
requirements laid down in the national legislation, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities;
c) 被授權人之職責可以進行委派，但
僅限於另一位被授權人。
c) The responsibilities of an Authorised Person may be delegated, but only to other Authorised Person(s).
2.7 生產部門的主管通常有下列職責： 2.7 The head of Production generally has the following responsibilities:
(i) 為獲得要求的品質，應確保該等產
品依適當的文件生產與儲存；
(i) To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;
(ii) 核准與生產作業有關的指令，並確 保其嚴格的實施；
(ii) To approve the instructions relating to production operations and to ensure their strict
implementation;
(iii) 確保生產紀錄已由經授權的人員 評估與簽章；
(iii) To ensure that the production records are evaluated and signed by an authorised person;
(iv) 確保其部門、廠房設施與設備的驗 證及維護保養；
(iv) To ensure the qualification and maintenance of his department, premises and equipment;
(v) 確保已完成適當的確效； (v) To ensure that the appropriate validations are done;
(vi) 確保其部門的人員已執行所要求 的職前與持續訓練，並依需求進行 調適。
(vi) To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
2.8 品質管制的主管通常有下列職責： 2.8 The head of Quality Control generally has the following responsibilities:
(i) 合適時，核准或拒用原料、包裝材 料、半製品/中間產品、待分/包裝 產品及最終產品；
(i) To approve or reject, as he/she sees fit, starting materials,
packaging materials, intermediate, bulk and finished products;
(ii) 確保已執行所有必要的試驗，且相 關紀錄也已進行評估；
(ii) To ensure that all necessary testing is carried out and the associated records evaluated;
(iii) 核准規格、抽樣指令、檢驗方法及 其他品質管制程序；
(iii) To approve specifications, sampling instructions, test methods and other Quality Control procedures;
(iv) 受託檢驗者之核准及監督； (iv) To approve and monitor any contract analysts;
(v) 確保其部門、廠房設施與設備的驗 證及維護保養；
(v) To ensure the qualification and maintenance of his/her
department, premises and equipment;
(vi) 確保已完成適當的確效； (vi) To ensure that the appropriate validations are done;
(vii) 確保其部門的人員已執行所要求 的職前與持續訓練，並依需求進行 調適。
(vii) To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
品質管制部門的其他職責概述於第六 章。
Other duties of Quality Control are summarised in Chapter 6.
2.9 生產和品質管制的主管，以及相關時品
質保證主管或品質單位主管，通常有一 些分擔或共同負擔之關於品質的職責，
特別包括製藥品質系統之設計、有效實 施、監測與維護。這些職責應受任何國 家法規的規範，包括：
2.9 The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities
relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. These may include, subject to any national regulations:
(i) 書面的程序和其他文件的認可，包 括修訂在內；
(i) The authorisation of written procedures and other documents, including amendments;
(ii) 製造環境的監測與管制； (ii) The monitoring and control of the manufacturing environment;
(iii) 工廠衛生； (iii) Plant hygiene;
(iv) 製程確效； (iv) Process validation;
(v) 訓練； (v) Training;
(vi) 原物料供應商的認可及監督； (vi) The approval and monitoring of suppliers of materials;
(vii) 受託製造廠以及其他 GMP 相關之 委外活動供應者的認可及監督；
(vii) The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
(viii) 原物料及產品之儲存條件的指示 與監測；
(viii) The designation and monitoring of storage conditions for materials and products;
(ix) 紀錄的保存； (ix) The retention of records;
(x) 符合 GMP 要求之監督； (x) The monitoring of compliance with the requirements of Good Manufacturing Practice;
(xi) 樣品的檢查、調查與抽取，以便監 測可能會影響產品品質的因素；
(xi) The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
(xii) 參與製程性能、產品品質與製藥品 質系統之管理審查，並倡導其持續 的改進；
(xii) Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement;
(xiii) 確保具備適時且有效的溝通及陳 報流程，以將品質議題提升到適當 管理階層的層級。
(xiii) Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
訓練（TRAINING）
2.10 藥廠對於因其職責會進入生產及儲存區 域或管制實驗室的所有人員(包括技術、
維修保養及清潔人員)，以及對於其活動 可能影響產品品質的其他人員，應提供 訓練。
2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
2.11 除了有關製藥品質系統與優良製造規範 的理論與實務基本訓練之外，新招募的 人員應接受適合於其指定職責之適當訓 練。同時也應提供持續的訓練，並應對 訓練的實際效果定期予以評估。應有視 情況經生產部門或品質管制部門的主管 核准的訓練計畫。訓練紀錄應予保存。
2.11 Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good
Manufacturing Practice, newly recruited personnel should receive training
appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed.
Training programmes should be
available, approved by either the head of Production or the head of Quality
Control, as appropriate. Training records should be kept.
2.12 對於在一有污染即產生危害之區域，例 如在潔淨區域或在處理高活性、毒性、
傳染性或致敏性物質之區域中工作的人 員，應給予特別的訓練。
2.12 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.
2.13 對於參訪人員及未受過訓練的人員，盡 量不要帶入生產區及品質管制區中。無 法避免時，應予事先提供資訊並密切監 督，特別是關於個人衛生及規定的防護 裝。
2.13 Visitors or untrained personnel should, preferably, not be taken into the
production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.
2.14 訓練期間，應充分討論製藥品質系統的 概念及所有能增進其理解與執行的措 施。
2.14 The Pharmaceutical Quality System and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.
人員衛生（PERSONNEL HYGIENE）
2.15 詳細的衛生計畫應予建立，並針對工廠
2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of
personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.
2.16 所有人員於雇用時皆應接受體檢。藥廠 應有職責建立指令，以確保人員與產品 品質可能有關之健康狀況會為藥廠所 悉。第一次體檢後，視工作與人員健康 之需要，應再執行體檢。
2.16 All personnel should receive medical examination upon recruitment. It must be the manufacturer’s responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer’s knowledge.
After the first medical examination, examinations should be carried out when necessary for the work and personal health.
2.17 應盡可能採取步驟，確保不會有受到傳
2.17 應盡可能採取步驟，確保不會有受到傳