24.03.2026

What Requirements must a Responsible Person for GDP meet?
[中譯] GDP 專任人員必須符合哪些要求？

The Responsible Person (RP) plays a central role within medicinal product wholesale distribution and across all GDP-relevant distribution activities within the scope of the wholesale distribution authorisation.
[中譯] 專任人員 (RP) 在藥品批發運銷及批發許可範圍內所有與 GDP 相關的運銷活動中扮演核心角色。

The RP ensures that the requirements of Good Distribution Practice (GDP) are complied with and that the quality, safety, and integrity of medicinal products are maintained throughout all activities performed under the wholesale authorisation.
[中譯] RP 負責確保符合優良運銷規範 (GDP) 要求，並在批發許可下的所有活動中維持藥品的品質、安全性與完整性。

With the increasing complexity of global supply chains, intensified regulatory focus on the prevention of falsified medicines, temperature-controlled supply chains, serialization and verification obligations, as well as a growing number of inspections, the importance of this function has significantly increased in recent years.
[中譯] 隨著全球供應鏈複雜化，法規對偽藥防範、溫控供應鏈、序列化與核驗義務的關注強化，加上稽核次數增加，此職能的重要性在近年顯著提升。

The RP is not merely a formal position; rather, the individual must be genuinely authorised and able to take and enforce quality-related decisions independently of commercial pressures.
[中譯] RP 不僅僅是一個形式上的職位；相反地，該人員必須獲得實質授權，並能獨立於商業壓力之外做出並執行品質相關決策。

Regulatory Framework
[中譯] 法規框架

Unlike the Qualified Person (QP) in the GMP environment, the formal educational requirements for the GDP Responsible Person are not exhaustively defined by legislation.
[中譯] 不同於 GMP 環境下的授權人員 (QP)，法律並未詳盡定義 GDP 專任人員的正式學歷要求。

The primary regulatory basis in the European Union is the “Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)”.
[中譯] 歐盟的主要法規依據為「2013 年 11 月 5 日人用藥品優良運銷規範指南 (2013/C 343/01)」。

Chapter 2.2 (Responsible Person) states: "The wholesale distributor must designate a person as responsible person. The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned. A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP."
[中譯] 指南第 2.2 節（專任人員）指出：「批發運銷商必須指定一人擔任專任人員。專任人員應符合相關會員國立法規定的資格與所有條件。具備藥學學位者尤佳。專任人員應具備適當的適任性與經驗，以及對 GDP 的知識與訓練。」

While the EU GDP Guidelines provide the regulatory framework, the specific qualification requirements and administrative expectations may differ between EU Member States.
[中譯] 儘管歐盟 GDP 指南提供了法規框架，但具體的資質要求與行政期望在歐盟各會員國之間可能有所不同。

National legislation and competent authorities may interpret and apply these requirements differently. Therefore, comapnies must always assess the applicable national provisions in addition to the EU GDP Guidelines.
[中譯] 各國法律與主管機關可能對這些要求有不同的解讀與應用。因此，企業除參考歐盟 GDP 指南外，必須始終評估適用的國家規定。

By way of example, in Germany the provisions of Section 52a of the German Medicinal Products Act (Arzneimittelgesetz – AMG) apply. A wholesale distribution authorisation is required for the wholesale distribution of medicinal products. Pursuant to Section 52a (2) No. 3 AMG, the applicant must designate a Responsible Person possessing the necessary expertise (Sachkenntnis) for the activity. However, the Act does not precisely define the scope and content of this expertise.
[中譯] 以德國為例，適用德國藥品法 (AMG) 第 52a 條。藥品批發運銷需取得許可，依據 AMG 第 52a (2) 條第 3 款，申請人必須指定一名具備該活動所需專業知識 (Sachkenntnis) 的專任人員。然而，該法並未精確定義此專業知識的範圍與內容。

This legal wording was further clarified by a judgment of the German Federal Administrative Court (Bundesverwaltungsgericht, judgment of 5 November 2020 – 3 C 7.19). The Court clarified that:
[中譯] 此法律措辭隨後經德國聯邦行政法院的一項裁定進一步釐清，法院明確指出：

• Pharmaceutical knowledge equivalent to formal pharmaceutical vocational training is not mandatory.
  [中譯] 並非強制要求等同於正式藥學職業訓練的藥學知識。
• The required expertise may be acquired through practical experience, particularly through activities performed under the guidance and supervision of a Responsible Person.
  [中譯] 所需的專業知識可透過實務經驗取得，特別是在專任人員的指導與監督下執行的活動。
• It is decisive that the Responsible Person possesses sufficient knowledge regarding the handling of the specific medicinal products distributed.
  [中譯] 關鍵在於專任人員對於處理所運銷之特定藥品具備充足知識。
• The requirements are case-specific and depend on the type, scope, and risk profile of the respective wholesale operation.
  [中譯] 相關要求視個案而定，取決於該批發營運的類型、規模與風險狀況。

The Court further emphasised that the Responsible Person is not required to personally conduct complex pharmaceutical-scientific risk assessments. However, the RP must be capable of obtaining expert assessments, understanding them, and evaluating their practical implementation.
[中譯] 法院進一步強調，專任人員無須親自執行複雜的藥學科學風險評估，但 RP 必須能夠獲取專家評估、理解內容並評估其實務執行情況。

This example illustrates that, although the EU GDP Guidelines establish a common regulatory baseline, national interpretation and jurisprudence may shape the concrete qualification profile required in a given Member State.
[中譯] 此案例說明，雖然歐盟 GDP 指南建立了共同的法規基準，但各國的解讀與法律見解可能會形塑該會員國具體的資質要求。

Professional and Personal Requirements of the Responsible Person for GDP
[中譯] GDP 專任人員之專業與個人要求

Although no specific academic degree is uniformly mandated across the EU, the following qualifications have proven appropriate in practice:
[中譯] 儘管歐盟境內並未統一規定特定的學術學位，但以下資格在實務上已被證實是合適的：

• Scientific, pharmaceutical, or technical background (e.g. pharmacy, chemistry, biology, logistics, engineering)
  [中譯] 科學、藥學或技術背景（如：藥學、化學、生物、物流、工程）。
• In-depth knowledge of GDP requirements
  [中譯] 對 GDP 要求有深入了解。
• Understanding of related regulatory frameworks such as GMP, pharmaceutical legislation, and falsified medicines legislation
  [中譯] 理解相關法規框架，如 GMP、藥事法規及偽藥防治法規。
• Experience in medicinal product wholesale distribution, logistics, or quality management
  [中譯] 具備藥品批發運銷、物流或品質管理經驗。

More important than the formal qualification is the demonstrable competence to correctly implement GDP requirements and to appropriately assess risks.
[中譯] 比正式資歷更重要的是具備可證明的適任性，以正確執行 GDP 要求並適當地評估風險。

Particularly relevant practical experience includes:
[中譯] 具高度相關性的實務經驗包括：

• Storage and transport of medicinal products
  [中譯] 藥品的儲存與運輸。
• Handling of temperature-controlled medicinal products
  [中譯] 處理溫控藥品。
• Supplier and service provider management
  [中譯] 供應商與服務提供者管理。
• Deviation and CAPA management
  [中譯] 偏差與矯正預防措施 (CAPA) 管理。
• Complaint handling and recall processes
  [中譯] 申訴處理與回收程序。

In addition to professional competence, the following personal attributes are essential:
[中譯] 除專業能力外，以下個人特質亦屬必要：

• Assertiveness towards operational departments
  [中譯] 對營運部門具備執行力。
• Decision-making capability in situations involving quality risks
  [中譯] 在涉及品質風險的情況下具備決策能力。
• Strong communication skills, particularly at organisational interfaces
  [中譯] 強大的溝通技巧，特別是在組織跨部門介面。
• Structured and risk-based thinking
  [中譯] 結構化與基於風險的思維。
• Integrity and sense of responsibility
  [中譯] 誠信與責任感。

The Responsible Person must also be able to set clear quality limits against commercial interests where necessary.
[中譯] 專任人員必須能夠在必要時，針對商業利益設定明確的品質界限。

Duties and Responsibilities in Practice
[中譯] 實務中的職責與責任

The responsibilities of the GDP Responsible Person are extensive and cover nearly all GDP-relevant processes.
[中譯] GDP 專任人員的職責廣泛，涵蓋幾乎所有與 GDP 相關的流程。

Quality Management System (QMS)
[中譯] 品質管理系統 (QMS)

• Establishment, maintenance, and oversight of the GDP Quality Management System
  [中譯] 建立、維護並監管 GDP 品質管理系統。
• Approval and implementation of GDP-relevant Standard Operating Procedures (SOPs)
  [中譯] 核准並執行 GDP 相關標準作業程序 (SOP)。
• Ensuring effective implementation in daily operations
  [中譯] 確保日常營運中的有效執行。

Storage and Transport
[中譯] 儲存與運輸

• Ensuring appropriate storage conditions
  [中譯] 確保適當的儲存條件。
• Evaluation and approval of transport concepts
  [中譯] 評估並核准運輸方案。
• Oversight and assessment of temperature excursions
  [中譯] 監管並評估溫度偏差情形。

Suppliers and Service Providers
[中譯] 供應商與服務提供者

• Qualification and monitoring of logistics service providers
  [中譯] 物流服務供應商的確認與監測。
• Assessment of outsourced activities
  [中譯] 委外活動評估。
• Approval and review of quality agreements and technical agreements
  [中譯] 核准並審查品質協議與技術協議。

Deviations, Complaints and Recalls
[中譯] 偏差、申訴與回收

• Evaluation of GDP deviations
  [中譯] 評估 GDP 偏差。
• Definition and follow-up of Corrective and Preventive Actions (CAPA)
  [中譯] 定義並追蹤矯正與預防措施 (CAPA)。
• Assessment of returned, falsified, or suspected falsified medicinal products
  [中譯] 評估退貨、偽藥或疑似偽藥。

Training and Self-Inspections
[中譯] 教育訓練與自我查核

• Ensuring regular GDP training
  [中譯] 確保定期的 GDP 訓練。
• Planning and conducting self-inspections
  [中譯] 規劃並執行自我查核。
• Preparation for and participation in regulatory inspections
  [中譯] 準備並參與主管機關稽核。

Organisational Requirements
[中譯] 組織要求

In accordance with the EU GDP Guidelines, the Responsible Person must:
[中譯] 根據歐盟 GDP 指南，專任人員必須：

• Have sufficient authority to fulfil the responsibilities
  [中譯] 擁有充足權限以履行職責。
• Operate within clearly defined reporting lines to senior management
  [中譯] 在與高階管理階層明確定義的報告線路內運作。
• Not be constrained by operational conflicts of interest
  [中譯] 不受營運利益衝突之限制。
• Have sufficient time to perform the assigned duties
  [中譯] 擁有充足時間執行指派的任務。

A purely nominal designation without actual authority and involvement is not acceptable to competent authorities.
[中譯] 缺乏實際權限與參與的純掛名職位，對於主管機關而言是不可接受的。

Practical Implementation – Typical Challenges
[中譯] 實務執行 – 典型挑戰

In practice, the following weaknesses are frequently observed:
[中譯] 在實務中，經常觀察到以下缺失：

• Unclear delineation of responsibilities and authority
  [中譯] 職責與權限劃分不明。
• Lack of deputy arrangements
  [中譯] 缺乏代理制度安排。
• Insufficient training
  [中譯] 教育訓練不足。
• Overburdening due to multiple roles
  [中譯] 因身兼多職導致負擔過重。
• Inadequate involvement in strategic decisions
  [中譯] 在策略決策中參與度不足。

A clearly defined role description and regular assessment of effectiveness are therefore essential to ensure ongoing GDP compliance.
[中譯] 因此，明確定義的角色說明與定期的有效性評估對於確保持續的 GDP 合規至關重要。

Recommendations for GDP Training
[中譯] GDP 訓練建議

To meet increasing regulatory expectations across the EU, comprehensive and continuous training is essential. Particularly recommended are training courses covering:
[中譯] 為因應歐盟各國日益增加的法規期望，全面且持續的教育訓練不可或缺。特別推薦涵蓋以下內容的課程：

• GDP fundamentals and implementation of a GDP Quality Management System
  [中譯] GDP 基礎知識與 GDP 品質管理系統的建立。
• Temperature management and cold chain control
  [中譯] 溫度管理與冷鏈控制。
• Handling of deviations and recalls
  [中譯] 偏差與回收處理。
• GDP audits and inspection preparedness
  [中譯] GDP 稽核與受審準備。
• Interfaces between GMP and GDP
  [中譯] GMP 與 GDP 的介接與交互影響。

Regular professional development is necessary to address evolving regulatory interpretations at both EU and Member State level, as well as emerging supply chain risks. The ECA also offers annual two-day training "The Responsible Person for Good Distribution Practice (GDP)" specifically focused on the tasks and responsibilities. Regular refresher training is necessary in order to adequately address regulatory changes and new risks. One suitable option for this is participation in the annual “GDP Update” webinar.
[中譯] 為應對歐盟與會員國層級不斷演進的法規解讀及新興供應鏈風險，定期的專業發展實屬必要。ECA 亦提供為期兩天的年度課程「GDP 專任人員」，專門針對其任務與責任。為妥善處理法規變更與新風險，必須進行定期的回訓訓練，參加年度「GDP 更新」網路研討會即是合適的選擇之一。

Working Groups and Further Information
[中譯] 工作小組與進一步資訊

As in other positions of regulatory responsibility, GDP Responsible Persons particularly benefit from professional exchange with peers. Regular dialogue enables the sharing of practical experience and supports the early assessment and interpretation of evolving regulatory expectations at both EU and national level. Examples include participation in professional associations or expert networks dedicated to GDP compliance. For instance, membership in the ECA European GDP Association or attendance at specialised conferences such as the biennial GMP & GDP Forum provide structured opportunities for knowledge exchange. Such platforms offer valuable insight into current inspection trends, competent authority expectations, and regulatory developments. They also support the practical and efficient implementation of new or revised requirements within the wholesale distributor’s Quality Management System.
[中譯] 如同其他法規責任職位，GDP 專任人員特別能從與同儕的專業交流中獲益。定期的對話有助於分享實務經驗，並支援歐盟及國家層級演進中法規期望的早期評估與解讀。範例包括參與致力於 GDP 合規的專業協會或專家網絡。例如：加入 ECA 歐洲 GDP 協會，或參加兩年一度的 GMP & GDP 論壇等專業會議，可提供結構化的知識交流機會。此類平台提供對當前稽核趨勢、主管機關期望及法規發展的寶貴見解，並支援批發運銷商品質管理系統中新修訂要求的實務高效執行。

出處：https://www.gmp-compliance.org/gmp-news/what-requirements-must-a-responsible-person-for-gdp-meet