原則（PRINCIPLE）
為了保護大眾健康，應具備一個系統及 適當程序用以記錄、評估、調查及檢討 包括潛在品質缺陷在內的申訴，必要時 有效與及時自運銷網回收人用藥品及研 究用藥品。品質風險管理原則應運用於 品質缺陷的調查與評估，以及與產品回 收矯正與預防行動及其他風險減低行動 相關的決策過程。與本原則相關之指引 提供於第一章。
In order to protect public and animal health, a system and appropriate
procedures should be in place to record, assess, investigate and review
complaints including potential quality defects, and if necessary, to effectively and promptly recall medicinal products for human or veterinary use and
investigational medicinal products from the distribution network. Quality Risk Management principles should be applied to the investigation and
assessment of quality defects and to the decision-making process in relation to product recalls corrective and
preventative actions and other risk-reducing actions. Guidance in relation to these principles is provided in Chapter 1.
當有品質缺陷（製造瑕疵、產品變質、
發現仿冒品、不符合上市許可或產品規 格檔案或任何其他嚴重品質問題）的情 況下，可能導致藥品或研究用藥品回收 或供應方面的異常限制時，應及時通知 所有相關之主管機關。在市場上之產品 被發現不符合上市許可的情況下，需要 通知相關主管機關。請參考相關法規要 求。
All concerned Competent Authorities should be informed in a timely manner in case of a confirmed quality defect (faulty manufacture, product
deterioration, detection of falsification, non-compliance with the marketing authorisation or product specification file, or any other serious quality problems) with a medicinal or investigational medicinal product which may result in the recall of the product or an abnormal restriction in the supply. In situations where product on the market is found to be
non-compliant with the marketing authorisation, there may be a requirement to notify concerned Competent Authorities. Reference should be made to relevant legislative requirements.
若有委外活動，合約應描述製造廠、上 市許可持有者及/或委託者以及任何其 他相關之第三方，在缺陷產品之評估、
決策、傳播資訊與實施風險減低行動方 面的角色及責任。有關合約的指引提供 於第七章。該等合約亦應敘述如何聯繫 品質缺陷管理及回收議題之各方責任 者。
In case of outsourced activities, a contract should describe the role and responsibilities of the manufacturer, the marketing authorisation holder and/or sponsor and any other relevant third parties in relation to assessment, decision-making, and dissemination of information and implementation of risk-reducing actions relating to a defective product. Guidance in relation to contracts is provided in Chapter 7.
Such contracts should also address how to contact those responsible at each party for the management of quality defect and recall issues.
人事與組織（PERSONNEL AND ORGANISATION）
8.1 應由經過適當訓練及有經驗之人員，負責 管理申訴與品質缺陷之調查，並決定採取 之措施以管理由這些問題（包括回收）所 帶來的任何潛在風險。除非有其他理由，
這些人員應與銷售部門相互獨立。如果這 些人員未包括所涉相關批次（一批或多 批）放行證明之被授權人，被授權人應及 時正式地執行任何調查、任何風險減低行 動及任何回收作業。
8.1 Appropriately trained and experienced personnel should be responsible for managing complaint and quality defect investigations and for deciding the measures to be taken to manage any potential risk(s) presented by those issues, including recalls. These persons should be independent of the sales and marketing organisation, unless otherwise justified. If these persons do not include the Authorised Person involved in the certification for release of the concerned batch or batches, the latter should be made formally aware of any
investigations, any risk-reducing actions and any recall operations, in a timely manner.
8.2 對於申訴與品質缺陷的處理、評估、調查 及檢討，以及實施任何風險減低行動，應 有足夠經訓練的人員與資源。對於與主管 機關互動之管理，亦應有足夠經訓練的人 員與資源。
8.2 Sufficient trained personnel and
resources should be made available for the handling, assessment, investigation and review of complaints and quality defects and for implementing any risk-reducing actions. Sufficient trained personnel and resources should also be available for the management of
interactions with Competent Authorities.
8.3 應考慮使用跨領域的團隊，包括經適當訓 練的品質管理人員在內。
8.3 The use of inter-disciplinary teams should be considered, including appropriately trained Quality Management personnel.
8.4 當申訴與品質缺陷處理在組織內由中央 統籌管理的情況下，相關各方的相關角色 與職責應加以文件化。但是，中央統籌管 理不應導致該問題調查及管理的延誤。
8.4 In situations in which complaint and quality defect handling is managed centrally within an organisation, the relative roles and responsibilities of the concerned parties should be documented.
Central management should not,
處理與調查申訴包括可能之品質缺陷在內的程序
（PROCEDURES FOR HANDLING AND INVESTIGATING COMPLAINTS INCLUDING POSSIBLE QUALITY DEFECTS）
8.5 應有書面程序說明接獲申訴時所要採取 之行動。所有申訴應加以文件化及評估，
以確定是否代表潛在的品質缺陷或其他 問題。
8.5 There should be written procedures describing the actions to be taken upon receipt of a complaint. All complaints should be documented and assessed to establish if they represent a potential quality defect or other issue.
8.6 應特別注意確定申訴或疑似品質缺陷是 否與偽造有關。
8.6 Special attention should be given to establishing whether a complaint or suspected quality defect relates to falsification.
8.7 由於公司接獲之所有申訴並非均代表實 際的品質缺陷，故未指出潛在品質缺陷之 申訴應予適當地文件化，並傳達給負責調 查與管理這類申訴的相關團隊或人員，例 如疑似不良事件。
8.7 As not all complaints received by a company may represent actual quality defects, complaints which do not indicate a potential quality defect should be documented appropriately and
communicated to the relevant group or person responsible for the investigation and management of complaints of that nature, such as suspected adverse events.
8.8 為了支持調查所提報的疑似不良事件，應 具備程序以利要求調查該批藥品的品質。
8.8 There should be procedures in place to facilitate a request to investigate the quality of a batch of a medicinal product in order to support an investigation into a reported suspected adverse event.
8.9 當啟動品質缺陷調查時，應具備程序以解 決至少下列事項：
8.9 When a quality defect investigation is initiated, procedures should be in place to address at least the following:
i 所提報之品質缺陷的描述。 i The description of the reported quality defect.
ii 品質缺陷程度的判定。對照及/或留 存樣品之檢查或檢驗應被視為其中 的一部分，在某些情況下，應執行 批次製造紀錄、批次認可紀錄及批 次運銷紀錄（特別是對溫度敏感的 產品）之檢討。
ii The determination of the extent of the quality defect. The checking or testing of reference and/or
retention samples should be considered as part of this, and in certain cases, a review of the batch production record, the batch certification record and the batch distribution records (especially for temperature-sensitive products) should be performed.
iii 需要向申訴人索取有缺陷產品的樣
品或者退回品，並且在有提供樣品 時，需要進行適當的評估。
iii The need to request a sample, or the return, of the defective product from the complainant and, where a sample is provided, the need for an appropriate evaluation to be
carried out.
iv 基於品質缺陷的嚴重性及程度，評
估品質缺陷造成的風險。
iv The assessment of the risk(s) posed by the quality defect, based on the severity and extent of the quality defect.
v 關於在運銷網中，可能需要採取風
險減低行動（如批次或產品回收）
或其他行動的決策過程。
v The decision-making process that is to be used concerning the potential need for risk-reducing actions to be taken in the
distribution network, such as batch or product recalls, or other actions.
vi 受回收行動影響之任何市場，對病
人藥品可得性衝擊之評估，並應將 該衝擊通知相關主管機關。
vi The assessment of the impact that any recall action may have on the availability of the medicinal product to patients/animals in any affected market, and the need to notify the relevant authorities of such impact.
vii 應就品質缺陷進行內部及外部之溝
通與調查。
vii The internal and external communications that should be
viii 識別品質缺陷的潛在根本原因。 viii The identification of the potential root cause(s) of the quality defect.
ix 需要對該問題識別與執行適當矯正
與預防行動，並評估該等矯正與預 防行動之有效性。
ix The need for appropriate
Corrective and Preventive Actions (CAPAs) to be identified and implemented for the issue, and for the assessment of the effectiveness of those CAPAs.
調查與決策（INVESTIGATION AND DECISION-MAKING）
8.10 所提報與可能之品質缺陷有關的資訊應 予記錄，包括所有的原始細節在內。為支 持所採取之相關調查及採取行動程度的 決定，所有提報之品質缺陷的正確性及範 圍應依照品質風險管理原則加以文件化 與評估。
8.10 The information reported in relation to possible quality defects should be recorded, including all the original details. The validity and extent of all reported quality defects should be documented and assessed in accordance with Quality Risk Management
principles in order to support decisions regarding the degree of investigation and action taken.
8.11 任一批 次中如 發現 或 懷疑有 品質瑕疵 時，應考慮檢查其他批次，或在某些情 況下檢查其他產品，以確定其是否也受 到影響。特別是可能含有該瑕疵批次之 部分或瑕疵組成物的其他批次應加以調 查。
8.11 If a quality defect is discovered or suspected in a batch, consideration should be given to checking other batches and in some cases other
products, in order to determine whether they are also affected. In particular, other batches which may contain portions of the defective batch or defective
components should be investigated.
8.12 品質缺陷調查應包括對過去品質缺陷報 告或任何其他相關資訊的檢討，以發現需 注意及可能進一步採取法規行動之特定 或重發性問題的任何跡象。
8.12 Quality defect investigations should include a review of previous quality defect reports or any other relevant information for any indication of specific or recurring problems requiring attention and possibly further regulatory action.
8.13 在品質缺陷調查過程中及其之後所作出 之決定應反映品質缺陷所呈現的風險程 度，以及不符合上市許可/產品規格檔案或 GMP 要求的嚴重性。該決定應是及時的 並採用與該些問題所呈現之風險程度相 稱的方式，以確保病患的安全。
8.13 The decisions that are made during and following quality defect investigations should reflect the level of risk that is presented by the quality defect as well as the seriousness of any non-compliance with respect to the requirements of the marketing authorisation/product
specification file or GMP. Such decisions should be timely to ensure that patient and animal safety is maintained, in a way that is commensurate with the level of risk that is presented by those issues.
8.14 由於品質缺陷之性質及程度的全面資訊 可能並非總是在調查早期階段可取得，因 此在該調查中決策過程仍應確保在適當 的時間點採取適當的風險減低行動。所有 因品質缺陷而採取之決策與措施皆應加 以文件化。
8.14 As comprehensive information on the nature and extent of the quality defect may not always be available at the early stages of an investigation, the
decision-making processes should still ensure that appropriate risk-reducing actions are taken at an appropriate time-point during such investigations.
All the decisions and measures taken as a result of a quality defect should be documented.
8.15 當品質缺陷可能造成產品回收或產品供 應異常限制的情況下，製造廠應及時向上 市許可持有者/委託者及所有相關主管機 關提報品質缺陷。
8.15 Quality defects should be reported in a timely manner by the manufacturer to the marketing authorisation holder/sponsor and all concerned Competent Authorities in cases where the quality defect may result in the recall of the product or in an abnormal restriction in the supply of the product.
根本原因分析及矯正與預防行動
（ROOT CAUSE ANALYSIS AND CORRECTIVE AND PREVENTATIVE
ACTIONS）
8.16 在品質缺陷調查過程中應進行適當程度 之根本原因分析工作。若無法確定品質缺 陷的根本原因，應考慮識別出最可能的根 本原因並解決這些問題。
8.16 An appropriate level of root cause analysis work should be applied during the investigation of quality defects. In cases where the true root cause(s) of the quality defect cannot be determined, consideration should be given to
identifying the most likely root cause(s) and to addressing those.
8.17 懷疑或識別人為錯誤為造成品質缺陷的 原因時，應正式證明其合理性並小心謹 慎，以確保未曾忽略製程、程序或基於系
統的錯誤或問題（若存在時）。
8.17 Where human error is suspected or identified as the cause of a quality defect, this should be formally justified and care should be exercised so as to ensure that process, procedural or system-based errors or problems are not overlooked, if
8.17 Where human error is suspected or identified as the cause of a quality defect, this should be formally justified and care should be exercised so as to ensure that process, procedural or system-based errors or problems are not overlooked, if