25.03.2026
What is Good Distribution Practice (GDP)?
[中譯] 什麼是藥品優良運銷規範 (GDP)？

Good Distribution Practice (GDP) is a key component of drug safety.
[中譯] 藥品優良運銷規範 (GDP) 是藥品安全的核心關鍵。

It describes the quality requirements for the distribution and logistics of human and veterinary medicinal products, as well as the active ingredients used in them, throughout the entire legal supply chain.
[中譯] 它描述了人用及動物用藥品，以及其中所使用之原料藥，在整個合法供應鏈中運銷與物流的品質要求。

The aim of GDP is to ensure that the quality, safety, and efficacy of medicinal products are not compromised from the manufacturer to the point of delivery to pharmacies, hospitals, or other authorized entities.
[中譯] GDP 的目標在於確保藥品從製造商到交付給藥局、醫院或其他獲授權機構的過程中，其品質、安全性與療效不受到影響。

While Good Manufacturing Practice (GMP) focuses on manufacturing activities, GDP directly follows on from GMP and governs all storage, transport, and distribution activities.
[中譯] 雖然優良製造規範 (GMP) 著重於製造活動，但 GDP 直接承接自 GMP，並規範了所有的儲存、運輸與運銷活動。

Due to increasingly complex international supply chains and rising requirements related to the prevention of counterfeit medicines, GDP has gained significant importance in recent years.
[中譯] 由於國際供應鏈日益複雜，以及防範偽藥的要求不斷提高，GDP 在近年來的重要性顯著提升。

Regulatory Basis
[中譯] 法規基礎
The key legal basis for GDP in the EU is:
[中譯] 歐盟 GDP 的主要法律依據為：

• EU GDP Guidelines for medicinal products for human use: The "Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)" establish standards for the proper handling, storage, and transport of medicinal products. Compliance with these guidelines is a prerequisite for obtaining and maintaining a wholesale distribution authorisation.
  [中譯] 歐盟人用藥品 GDP 指南：2013年11月5日頒佈之「人用藥品優良運銷規範指南 (2013/C 343/01)」建立了藥品妥善處理、儲存與運輸的標準。符合此指南是取得與維持批發運銷許可的必要條件。
• EU GDP Guidelines for active substances for human medicinal products: The “Guidelines of 19 March 2015 on the principles of Good Distribution Practice for active substances for human use (2015/C 95/01)” apply to the distribution of active substances intended for use in human medicinal products. Their purpose is to ensure that the quality and integrity of active substances are maintained throughout the entire supply chain.
  [中譯] 歐盟人用藥品原料藥 GDP 指南：2015年3月19日頒佈之「人用原料藥優良運銷規範原則指南 (2015/C 95/01)」適用於供人用藥品使用之原料藥運銷。其目的在於確保原料藥的品質與完整性在整個供應鏈中得以維持。
• Good Distribution Practice for veterinary medicinal products: "Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council" entered into force in August 2021. This implementing regulation is closely aligned with the GDP guidelines for human medicinal products.
  [中譯] 動物用藥品優良運銷規範：依據歐洲議會與理事會法規 (EU) 2019/6，於2021年7月29日頒佈之「委員會執行規章 (EU) 2021/1248」已於2021年8月生效。該執行規章與人用藥品 GDP 指南高度一致。
• Good Distribution Practice for active substances used as starting materials for veterinary medicinal products: Since August 2021, "Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council" has been applicable.
  [中譯] 動物用藥起始原料之原料藥優良運銷規範：自2021年8月起，適用於「委員會執行規章 (EU) 2021/1280」，其規範了動物用藥品起始原料之原料藥運銷措施。

The following topics, among others, are covered:
[中譯] 涵蓋的主題包含（但不限於）：

• Quality system [中譯] 品質系統
• Personnel and responsibilities [中譯] 人員與職責
• Premises and equipment [中譯] 場所與設備
• Documentation [中譯] 文件紀錄
• Storage and transport [中譯] 儲存與運輸
• Complaints, recalls, and returns [中譯] 申訴、回收與退貨
• Management of outsourced activities and supplier qualification [中譯] 委外作業管理與供應商評鑑 (Qualification)
• Self-inspections [中譯] 自我查核

A central principle of GDP is the risk-based approach, which is aligned with the principles of Quality Risk Management.
[中譯] GDP 的核心原則是風險導向方法 (Risk-based approach)，這與品質風險管理 (QRM) 的原則一致。

In addition to EU requirements, several national laws and regulations govern the wholesale distribution of medicinal products.
[中譯] 除了歐盟要求外，各國亦有法律規範藥品批發運銷。

In the United States, there is no standalone GDP guideline equivalent to that of the EU. However, comparable requirements are embedded within the regulatory framework, in particular through:
[中譯] 在美國，並沒有與歐盟對等的獨立 GDP 指南。然而，類似的要求已嵌入監管框架中，特別是透過：

• Federal Food, Drug, and Cosmetic Act (FD&C Act) [中譯] 聯邦食品、藥物和化妝品法案
• 21 CFR Parts 203, 205 and 211 [中譯] 美國聯邦法規第 21 條第 203、205 與 211 部分
• FDA guidances on Supply Chain Security and the Drug Supply Chain Security Act (DSCSA) [中譯] FDA 關於供應鏈安全與藥品供應鏈安全法案 (DSCSA) 的指南

The FDA typically addresses distribution-related processes during GMP inspections or in the context of investigations related to counterfeit medicines, temperature excursions, or product recalls.
[中譯] FDA 通常會在 GMP 查核期間，或針對偽藥、溫度偏移 (Temperature excursions) 或產品回收調查時，處理與運銷相關的製程。

Core GDP Requirements and Practical Implementation
[中譯] GDP 核心要求與實務執行
GDP requires a documented and effectively implemented quality management system that covers all distribution activities.
[中譯] GDP 要求建立文件化且有效執行的品質管理系統，以涵蓋所有運銷活動。

Senior management bears overall responsibility for compliance with GDP requirements.
[中譯] 高層管理階層對符合 GDP 要求負有全面責任。

A key element of GDP is the appointment of a Responsible Person, who ensures that all GDP-relevant processes are complied with.
[中譯] GDP 的關鍵要素是任命一位負責人 (Responsible Person)，負責確保所有 GDP 相關流程均符合規範。

Controlled storage and transport of medicinal products are also essential components of GDP.
[中譯] 藥品的受控儲存與運輸亦是 GDP 的必要組成部分。

Deviations, such as temperature excursions, must be assessed and documented and, where necessary, may result in quarantine or destruction of the affected products.
[中譯] 偏差（如溫度偏移）必須經過評估與記錄，必要時可能導致受影響產品被隔離或銷毀。

GDP requires complete and traceable documentation to ensure that the origin of each medicinal product is known and all distribution routes can be reconstructed.
[中譯] GDP 要求完整且具追溯性的文件紀錄，以確保每種藥品的來源已知且所有運銷路徑皆可重建。

Practical Implementation of GDP
[中譯] GDP 的實務執行
In practice, GDP requires not only the existence of standard operating procedures (SOPs) but also their consistent application in daily operations.
[中譯] 在實務上，GDP 不僅要求具備標準作業程序 (SOP)，更要求在日常作業中一致地落實執行。

The qualification and ongoing supervision of external service providers are particularly important, as outsourced activities remain the responsibility of the contracting company.
[中譯] 外部服務供應商的評鑑 (Qualification) 與持續監督尤為重要，因為委外作業的責任仍歸屬於委託公司。

Source: https://www.gmp-compliance.org/gmp-news/what-is-good-distribution-practice-gdp
[中譯] 來源：https://www.gmp-compliance.org/gmp-news/what-is-good-distribution-practice-gdp