原則（PRINCIPLE）
一套令人滿意之品質保證系統的建立和 維持，以及藥品的正確製造，均仰賴人 員。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 establishment and maintenance of a satisfactory system of quality assurance and 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。賦予每一個人的責任不應過 廣，以致呈現對於品質的風險。
2.1 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience.
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。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。
2.2 The manufacturer must have an
organisation chart. 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.
關鍵人員（KEY PERSONNEL）
2.3 關鍵人 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 定的被授權人員。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 2.5、2.6 及 2.7 中所列之部 分職務。
2.3 Key Personnel includes 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 2.5., 2.6. and 2.7.
2.4 … 2.4 …
2.5 生產部門的主管通常有下列職責： 2.5 The head of the Production Department 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. 確保生產紀錄送到品質管制部門前，已 由被授權人員評估與簽章；
iii. to ensure that the production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department;
iv. 檢查/核對其部門、廠房設施及設備的維 護保養；
iv. to check the 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.
2.6 品質管制部門的主管通常有下列職責： 2.6 The head of the Quality Control
Department 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 sees fit, starting materials, packaging materials, and intermediate, bulk and finished products;
ii. 評估批次紀錄； ii. to evaluate batch records;
iii. 確保已執行所有必要的試驗； iii. to ensure that all necessary testing is carried out;
iv. 核准規格、抽樣指令、檢驗方法及其他 品質管制程序；
iv. to approve specifications, sampling instructions, test methods and other Quality Control procedures;
v. 受託檢驗者之核准及監督； v. to approve and monitor any contract analysts;
vi. 檢查/核對其部門、廠房設施與設備的維 護保養；
vi. to check the maintenance of his department, premises and equipment;
vii. 確保已完成適當的確效； vii. to ensure that the appropriate validations are done;
viii. 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。
品質管制部門的其他職責概述於第六 章。
viii. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. Other duties of the Quality Control Department are summarised in Chapter 6.
2.7 生產和品質管制的主管通常有一些分擔 或共同負擔之關於品質的職責。這些職 責應受國家法規的規範，包括：
2.7 The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, subject to any national regulations:
書面的程序和其他文件的認可，包括修 訂在內；
the authorisation of written procedures and other documents, including
amendments;
製造環境的監測與管制； the monitoring and control of the manufacturing environment;
工廠衛生； plant hygiene;
製程確效； process validation;
訓練； training;
原物料供應商的認可及監督； the approval and monitoring of suppliers of materials;
受託製造廠的認可及監督； the approval and monitoring of contract manufacturers;
原物料及產品之儲存條件的指示與監 測；
the designation and monitoring of storage conditions for materials and products;
紀錄的保存； the retention of records;
符合 GMP 要求之監督； the monitoring of compliance with the requirements of GMP;
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。
the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
訓練（TRAINING）
2.8 藥廠對於因其職責會進入生產區或管制 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。
2.8 The manufacturer should provide training for all the personnel whose duties take them into production 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.
2.9 除了有關優良製造規範的理論與實務的 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。
2.9 Beside the basic training on the theory and practice of 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.
2.10 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。
2.10 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.
2.11 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。
2.11 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.
2.12 訓練期間，應充分討論品質保證的概念 及所有能增進其理解與執行的措施。
2.12 The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.
個人衛生（PERSONAL HYGIENE）
2.13 詳細的衛生計畫應予建立，並針對工廠 內的不同需求調適。該計畫應包括人員 健康、衛生習慣及服裝等相關程序。因 其職責而進入生產區及管制區的每個人 員，皆應了解這些程序並嚴格遵守。管 理階層應推動衛生計畫並在訓練期間予 以廣泛討論。
2.13 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.
2.14 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。
2.14 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.
2.15 應盡可能採取步驟，確保不會有受到傳 染性疾病感染的人或在暴露的身體表面 上有開放性傷口的人從事於藥品的製 造。
2.15 Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.
2.16 進入製造區的每個人員皆應穿戴適合其 所要執行操作之防護裝。
2.16 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.
2.17 生產區及儲存區應禁止飲食、嚼食或吸 煙，或是儲存食物、飲料、菸類或個人 的醫療用品。通常在製造區或產品可能 會受到不良影響的任何其他區域中，應 禁止任何不合衛生的行為。
2.17 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected, should be forbidden.
2.18 工作人員應避免雙手直接接觸暴露的產 品及與產品接觸之設備的任何部分。
2.18 Direct contact should be avoided between the operator's hands and the exposed product as well as with any part of the equipment that comes into contact with the products.
2.19 應指導工作人員使用洗手設施。 2.19 Personnel should be instructed to use the hand-washing facilities.
2.20 其他任何特定的要求，例如製造無菌製 劑等特殊類別的產品，收載於相關補充 指引中。
2.20 Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the Supplementary Guidelines.