西藥藥品優良製造規範
（第三部：運銷）
PIC/S：Guide to Good Distribution Practice for Medicinal Products
PE011-1 (1 June 2014)
© PIC/S January 2014
衛生福利部
中華民國 104 年 7 月
序
之國際競爭力，衛生福利部食品藥物管理署將藥品運銷管理列為近年施政首要 目標之一，以期建構健全完善藥品供應鏈體系。
今日，全球化趨勢與跨國專業分工使得藥品供應鏈更加複雜，為有效確保藥 品品質，藥品管理政策應涵蓋藥品供應鏈。為保障藥品從出廠後至使用前之品 質，世界各國衛生主管機關對於藥品品質的要求已從過去生產面向的「藥品優 良製造規範」（Good Manufacturing Practice，GMP）延伸到運銷面向的「藥品 優良運銷規範」（Good Distribution Practice，GDP）。
國際間目前已有許多組織及國家開始實施 GDP，包含世界衛生組織、歐盟、
新加坡、馬來西亞、英國、德國、瑞士、美國與澳洲等，我國亦於 102 年 10 月 檢送 PIC/S GDP 草案內容之中英對照予各藥業公協會轉知所屬會員參考。國際 醫藥品稽查協約組織（Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme，PIC/S）於 103 年 6 月正式公布其 GDP，此規範 未來勢必成為國際 GDP 標準，因此藉由推動與國際同步之 GDP，落實藥品運銷 品質管理，不僅可保障全體國人用藥安全，進一步更能提升我國藥品運銷品質 並創造國際競爭力。
PIC/S 組織所公布之 GDP 分為前言、目的、範圍、條文內容及術語表，條文 內容包含品質管理、人事、作業場所及設備、文件管理、作業、申訴、退回、
疑似偽、禁藥及藥品回收、委外作業、自我查核、運輸，總計九章。其適用範 圍為所有藥品批發運銷活動，包含所有藥品採購、儲存、供應、輸入及輸出等 ， 其適用產品類型為人用藥品及類似產品。此規範具體說明藥品運銷活動應建構 之硬體設施與應建置的文件系統，提供從事批發運銷活動業者明確之指引，進 而強化藥品運銷管控，維護藥品品質與完整性。未來 PIC/S 組織更新 GDP 條文 時，本署配合隨時更新西藥藥品優良製造規範（第三部：運銷）（以下簡稱本 規範）。
衛生福利部食品藥物管理署 中華民國 104 年 5 月
目錄
(Table of Contents)
前 言 ---1 目 的 ---2 範 圍 ---3
第一章 品質管理 (QUALITY MANAGEMENT)---4
第二章 人事 (PERSONNEL)---7
第三章 作業場所及設備 (PREMISES AND EQUIPMENT)---10
第四章 文件管理 (DOCUMENTATION)---16
第五章 作業 (OPERATIONS)---18
第六章 申訴、退回、疑似偽、禁藥及藥品回收 (COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS)---22
第七章 委外作業 (OUTSOURCED ACTIVITIES)---27
第八章 自我查核 (SELF-INSPECTIONS)---28
第九章 運輸 (TRANSPORTATION)---29
附件一 術語表 (GLOSSARY OF TERMS) 34
1. 本規範係採 PIC/S GDP （ PE011-1 ) 制訂，考量本國國情及現況，將 部分條文酌修，以符合國內法令之規定，且本規範僅適用人用西藥 藥品。
2. 本規範所指批發運銷商係進行藥事法中批發運銷相關活動之我國藥 品販賣業者及藥品製造業者。
前言 INTRODUCTION
本規範是以歐盟對於人用藥之「藥 品優良運銷規範」指引為基礎 (2013/C 343/01)。該指引已被 GDP 專家圈為 PIC/S 之目的採用，且本 規範已刪除歐盟專用資料。
本規範已被 PIC/S 採用作為指引文 件。各 PIC/S 會員主管機關應自行 決定是否採用本規範作為具有法律 約束力之標準。
This Guide is based on the EU Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use
(2013/C 343/01). The EU Guidelines have been adapted by the Expert Circle on GDP for PIC/S purposes. However, the EU specific
references have been deleted in this Guide.
This Guide has been adopted by PIC/S as a guidance document. It is up to each PIC/S Participating Authority to decide whether it should become a legally-binding
standard.
藥品的批發運銷是整合供應鏈管理 中重要的活動。現今的藥品運銷網 絡日益複雜且包含許多參與者。本 規範制定適當的工具以協助批發運 銷商進行其活動，並預防偽、禁藥 流入合法供應鏈中。遵守本規範可 確保運銷鏈的管控，進而維護藥品 的品質與完整性。
The wholesale distribution of medicinal products is an important activity in integrated supply chain management.
Today’s distribution network for medicinal products is increasingly complex and involves many players. These guidelines lay down appropriate tools to assist
wholesale distributors in conducting their activities and to prevent falsified
medicines from entering the legal supply chain. Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.
藥品批發運銷指的是藥品採購、儲 存、供應、輸入或輸出的所有活 動，但不包含供應藥品給大眾。這 類活動是由製造商或其受託者、進 口商、其他批發運銷商或由藥師及 經授權供應藥品給大眾的人員執 行。在某些 PIC/S 會員主管機關的
Wholesale distribution of medicinal products is all activities consisting of procuring, holding, supplying, importing or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories,
國家，輸入可能被列入 GMP 的範圍 內，且可能需要提供製造許可。
importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public. In the territories of some PIC/S Participating Authorities importation may fall under GMP and a manufacturer’s license may be required.
任何扮演批發運銷商角色者，應符 合國內法令之要求。
持有藥品製造許可包含該許可所涵 蓋之藥品運銷，因此，製造廠執行 任何自家產品的運銷作業必須遵守 GDP。
Any person acting as a wholesale distributor has to hold a wholesale distribution licence in accordance with national legislation.
Possession of a manufacturing licence includes authorisation to distribute the medicinal products covered by the
authorisation. Manufacturers performing any distribution activities with their own products must therefore comply with GDP.
批發運銷的定義並非取決於運銷商 是否於特定海關領域內建立或營 運，例如在自由貿易區或自由倉 庫。所有與批發運銷活動相關的責 任(例如輸入、輸出、儲存或供應) 也適用於這類運銷商。其他參與運 銷藥品的業者也應遵守本規範的相 關章節。
本規範所使用的術語表包含於附件 一中。
The definition of wholesale distribution does not depend on whether that
distributor is established or operating in specific customs areas, such as in free zones or in free warehouses. All obligations related to wholesale
distribution activities (such as importing, exporting, holding or supplying) also apply to these distributors. Relevant
sections of these guidelines should also be adhered to by other actors involved in the distribution of medicinal products.
A glossary of some terms used in the Guide has been incorporated as Annex 1.
目的 PURPOSE
確保維持藥品運銷過程中高標準的 品質保證與完整性、促進藥品批發 許可的一致及進一步消除藥品貿易 障礙，而採用本規範。
國家衛生主管機關的行政措施應針 對這些標準應用在實務上，且任何 針對本規範的新或修正法規應至少 符合其水準。這類標準也提供批發 運銷商作為制訂符合其個別需求的 具體規則之基礎。除了本規範說明 之外，尚有其他可被接受的方法也 能達到原則。本文件可作為稽查準 備之指引，也可用於訓練之目的。
In order to ensure the maintaining of high standards of quality assurance and the integrity of the distribution processes of medicinal products, to promote uniformity in licensing of wholesaling of medicinal products and to further facilitate the removal of barriers to trade in medicinal products, the following Guide to Good Distribution Practice (GDP) for Medicinal Products has been adopted.
Administrative measures of national health authorities should be directed towards the
application of these standards in practice, and any new or amended national
regulations for good distribution practice should at least meet their level.
These standards are also intended to serve wholesale distributors as a basis for the elaboration of specific rules adapted to their individual needs. It is recognised that there are acceptable methods, other than those described in this Guide, which are capable of achieving the principles of the Guide. This document provides guidance for preparation for inspections and may be used for training purposes.
範圍 SCOPE
本文所載之標準適用於人用藥品與 類似產品。本規範也適用於研究用 藥品(IMP)。
本文件在發行時反映出目前的技術 水準。其目的不在於對技術創新或 追求卓越上造成障礙，或限制新概 念或新技術的發展，新概念或技術 應經確效，並提供相當程度之品質 保證與運銷流程的完整性，至少應 等同於本規範之標準。
The standards set out herein apply to medicines and similar products intended for human use. It is recommended,
however, that the same kind of attention be given to the distribution of veterinary medicinal products. This guideline can also be applicable for Investigational Medicinal Products (IMP).
At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence or to place any restraint upon the
development of new concepts or new technologies, which have been validated and provide a level of Quality Assurance and integrity of the distribution processes at least equivalent to those set out in this Guide.
第 1 章 品質管理 (Chapter 1 Quality Management)
1.1 原則 (Principle)
批發運銷商應訂定一套與其活動 相關的職責、流程及風險管理原
則的品質系統。 Wholesale distributors should maintain a quality system setting out
responsibilities, processes and risk management principles in relation to their activities.
所有運銷活動在程序上應清楚規 範，並且經過系統式審查，運銷 流程的所有關鍵性步驟與重大變 更都應證明其正當性並確效。
All distribution activities should be clearly defined in procedures and systematically reviewed. All critical steps of distribution processes and significant changes should be justified and where relevant validated.
品質系統是管理者的責任，且需 要其領導能力及積極參與，以及
員工的承諾予以支持。 The quality system is the responsibility of the organisation’s management and requires their leadership and active participation and should be supported by staff commitment.
1.2 品質系統 (Quality System)
1.2.1 品質系統應包含組織架構、程
序、流程、資源及必要活動，以 確保儲存及/或運輸時交付的產品 維持其品質及完整性，並來自合 法供應鏈。
The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and/or transportation.
1.2.2
品質系統應充分文件化，並監測 其有效性；所有與品質系統相關 的活動應予以規範及記錄；應訂 定品質手冊或類似文件。
The quality system should be fully documented and its effectiveness monitored. All quality system related activities should be defined and documented. A quality manual or equivalent documentation approach should be established
1.2.3 被指定之權責人員應由管理階層 指派，其職權及職責應清楚明 定，以確保品質系統的執行及維 持。
Designated responsible person(s) should be appointed by the management, who should have clearly specified authority and responsibility for ensuring that a quality system is implemented and maintained.
1.2.4 運銷商的管理者應確保品質系統
皆有勝任之人員及適當足夠的作 業場所、設備及設施等資源。
The management of the distributor should ensure that all parts of the quality system are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
1.2.5 發展或修改品質系統時，應考量
運銷商活動的規模、架構及複雜 性。
The size, structure and complexity of distributor’s activities should be taken into consideration when developing or modifying the quality system.
1.2.6 應具備變更管制系統，此系統應
包含品質風險管理原則，且應依 照風險比例有效的設置此系統。
A change control system should be in place. This system should incorporate quality risk management principles, and be proportionate and effective.
1.2.7 品質系統應確保：
The quality system should ensure that:
i)藥品的採購、儲存、供應、輸入
或輸出均符合本規範的要求； i)medicinal products are procured, held, supplied, imported or exported in a way that is compliant with the requirements of GDP;
ii)管理職責經清楚的明定； ii)management responsibilities are clearly specified;
iii)產品在適當的期間內交付給正
確的接受者； iii)products are delivered to the right recipients within a satisfactory time period;
iv)於執行活動的同時進行記錄； iv)records are made contemporaneously;
v)偏差要予以文件化與調查；
v)deviations from established procedures are documented and investigated;
vi) 依照品質風險管理原則，採取
iv)appropriate corrective and preventive
適當的矯正預防措施(CAPA)，矯
正並預防偏差情況。 actions (commonly known as CAPA) are taken to correct deviations and prevent them in line with the principles of quality risk management.
1.3 委外作業管理 (Management of Outsourced Activities) 品質系統應擴大到任何關於藥品
採購、儲存、供應、輸入或輸出 之委外作業的管制及審查。此流 程應納入品質風險管理並包含：
The quality system should extend to the control and review of any outsourced activities related to the procurement, holding, supply, import or export of medicinal products. These processes should incorporate quality risk management and include:
i)評估受託者執行活動之適任性與
能力、藥品保存之完整性與安全
性及文件維護，必要時檢查許可 及市場狀態；
i)assessing the suitability and
competence of the Contract Acceptor to carry out the activity, preserving the integrity and security of the medicinal products, and requesting, preserving documentation, and checking
authorisation or marketing status, if required;
ii)規範參與品質相關活動者的職
責及溝通流程。 ii)defining the responsibilities and communication processes for the quality-related activities of the parties involved;
iii)定期監測及審查受託者的績 效，並識別及執行任何必須改善 之處。
iii) monitoring and review of the performance of the Contract Acceptor, and the identification and
implementation of any required improvements on a regular basis.
1.4 管理階層檢討及監督 (Management Review and Monitoring)
1.4.1 管理階層應依正式流程定期檢討
品質系統，其檢討應包括： The management should have a formal process for reviewing the quality system on a periodic basis. The review should include:
i)達成品質系統目標的評量； i)measurement of the achievement of quality system objectives;
ii)評估可用來監測品質系統內流 程有效性的績效指標，如申訴、
回收、退回、偏差、矯正預防措 施(CAPA)、流程變更；委外作業 的回饋意見；自我評估流程，包 括風險評估及稽核；外部評估，
如主管機關的查核與調查結果及 客戶的稽核。
ii)assessment of performance indicators that can be used to monitor the
effectiveness of processes within the quality system, such as complaints, recalls, returns, deviations, CAPA, changes to processes; feedback on outsourced activities; self-assessment processes including risk assessments and audits; and external assessments such as inspections, findings and customer audits;
iii)新法規、指引以及會影響品質
管理系統的品質議題； iii)emerging regulations, guidance and quality issues that can impact the quality management system;
iv)可增進品質系統之改革； iv)innovations that might enhance the quality system;
v)商業環境及目標的變更。
v)changes in business environment and objectives.
1.4.2 每一項品質系統的檢討結果應即
時記錄並有效地進行內部溝通。 The outcome of each management review of the quality system should be documented in a timely manner and effectively communicated internally.
1.5 品質風險管理 (Quality Risk Management)
1.5.1 品質風險管理是可用以評估、管
制、溝通及審查藥品品質風險之 系統性流程。其適用方式可採主 動性及回溯性兩種。
Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of medicinal products. It can be applied both proactively and
retrospectively.
1.5.2 品質風險管理應確保品質風險評
估是以科學知識、流程經驗及最 終連結到病患保護為主。此流程 的執行、形式及文件應與風險等 級相當。
品質風險管理的流程及應用範例 可參見 ICH(International
Conference on Harmonisation)Q9 指引。
Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge,
experience with the process and
ultimately links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk.
Examples of the processes and
applications of quality risk management
can be found in guideline Q9 of the International Conference on
Harmonisation (ICH).
第 2 章 人事 (Chapter 2 Personnel) 2.1 原則 (Principle)
藥品的正確運銷仰賴人員。為 此，批發運銷商須配置足夠的勝 任人員執行其所有負責之工作。
工作人員應清楚瞭解其個別職責 並作成紀錄。
The correct distribution of medicinal products relies upon people. For this reason, there must be sufficient
competent personnel to carry out all the tasks for which the wholesale distributor is responsible. Individual responsibilities should be clearly understood by the staff and be recorded.
2.2 一般規定(General)
2.2.1 參與所有階段的藥品批發運銷活
動應具備足夠數量的勝任人員，
所需人員數量視作業量及作業範 圍而定。
There should be an adequate number of competent personnel involved in all stages of the wholesale distribution activities of medicinal products. The number of personnel required will depend on the volume and scope of activities.
2.2.2 批發運銷商的組織圖需界定組織
架構，並清楚標示所有人員的角 色、職責以及相互關係。
The organisational structure of the wholesale distributor should be set out in an organisation chart. The role,
responsibilities, and interrelationships of all personnel should be clearly indicated.
2.2.3 關鍵人員的角色、職責及代理人
制度之安排，應建立書面職務說
明。 The role and responsibilities of employees working in key positions should be set out in written job descriptions, along with any arrangements for deputising.
2.3 職責之指派 (Designation of responsibilities)
2.3.1 批發運銷商必須指定權責人員確
保作業符合本規範。相關人員應 具有適當的能力與經驗，以及瞭 解本規範與接受有關本規範之相 關訓練。
The wholesale distributor must
designate personnel responsible for GDP compliance. Relevant personnel should have appropriate competence and
experience as well as knowledge of and training in GDP.
2.3.2 批發運銷商應提供非營業時段之 Wholesale distributors should nominate
聯繫人員（如緊急事件、回 收）。被指定之權責人員可指派 職務代理人，但仍需擔負此責 任。
personnel for out of hours contact (e.g.
emergencies and/or recall). Designated responsible person(s) may delegate duties but not responsibilities.
2.3.3 被指定之權責人員之書面職務說
明應規範與其職責相關決策的授 權。批發運銷商應給予指定之權 責人員完成其職務所需之權限、
適當資源及職責。
Written job descriptions for designated responsible person(s) should define their authority to take decisions with regard to their responsibilities. The wholesale distributor should give the designated responsible person(s) the defined authority, adequate resources and responsibility needed to fulfil their duties.
2.3.4 被指定之權責人員應以確保批發
運銷商遵守本規範且履行公共服 務責任的方式執行其職責。
Designated responsible person(s) should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
2.3.5 被指定之權責人員的職責包括，
但不侷限於： The responsibilities of the designated responsible person(s) include but are not limited to:
i)確保品質管理系統之執行及維
持； i) ensuring that a quality management system is implemented and maintained;
ii)著重於被授權活動之管理及紀
錄真實性與品質； ii) focusing on the management of authorised activities and the accuracy and quality of records;
iii)確保職前及持續訓練計畫之執 行及維持；
iii) ensuring that initial and continuous training programmes are implemented and maintained;
iv)協調及立即執行任何藥品回收 作業；
iv) coordinating and promptly
performing any recall operations for medicinal products;
v)確保有效處理客戶申訴； v) ensuring that relevant customer complaints are dealt with effectively;
vi)確保供應商及客戶經核准 vi) ensuring that suppliers and customers are approved;
vii)核准所有可能影響符合本規範
之轉委託作業 vii) approving any subcontracted activities which may impact on GDP;
viii)確保事先安排計畫，在適當的 定期間隔內進行自我查核，且應 執行必要的矯正措施；
viii) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective
measures are put in place;
ix)保存關於職務代理的適當紀 錄；
ix) keeping appropriate records of any delegated duties;
x)所有退回、拒用、回收、偽、
禁藥的最終處理判定。 x) deciding on the final disposition of returned, rejected, recalled or falsified products;
xi)核准退回品進入可銷售品庫
存； xi) approving any returns to saleable stock;
xii)確保遵守國內法令對特定產品
所附加的其他要求 xii) ensuring that any additional requirements imposed on certain products by national legislation are adhered to.
2.4 訓練 (Training)
2.4.1 參與批發運銷活動的所有人員應
接受本規範要求之訓練，在開始 執行作業前應具有適當能力及經 驗。
All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks.
2.4.2 人員應依照書面程序及訓練計
畫，接受與其職務相關的職前及 持續訓練。被指定之權責人員也 應透過定期訓練維持其本規範之 執行能力。
Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. Designated responsible person(s) should also maintain their competence in GDP through regular training.
2.4.3 此外，訓練應包括產品識別以及
避免偽、禁藥進入供應鏈。 In addition, training should include the supply chain.
2.4.4 需以嚴謹條件處理之產品，其負
責人員應接受特定訓練。這類產 品如：有危害性之產品、放射性 物質、有特定濫用風險之產品(包 含麻醉藥、治療精神異常用藥)及 對溫度敏感的產品。
Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and
temperature-sensitive products.
2.4.5
應保存所有訓練紀錄，且訓練的
有效性應定期評估及文件化。 A record of all training should be kept, and the effectiveness of training should be periodically assessed and
documented.
2.5 衛生 (Hygiene)
在執行作業時，應制定及遵守與 人員衛生相關之程序，包括健 康、衛生習慣與服裝。
Appropriate procedures relating to personnel hygiene, relevant to the activities being carried out, should be established and observed. Such
procedures should cover health, hygiene and clothing.
第 3 章作業場所及設備 (Chapter 3 Premises and Equipment) 3.1 原則 (Principle)
批發運銷商必須具備適當且足夠 的作業場所、配備及設備，以確 保能夠適當儲存及運銷藥品，此 作業場所必須是潔淨、乾燥及維 持在可接受的溫度範圍內。
Wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In particular, the premises should be clean, dry and maintained within acceptable temperature limits.
3.2 作業場所 (Premises)
3.2.1 作業場所應設計或調適以確保維
持所需的儲存條件。作業場所應 具有適當安全性，結構要完善且 有足夠的容量可安全儲存及處理 藥品。儲存空間應提供適當的照 明及通風以精確及安全地執行所 有作業。
The premises should be designed or adapted to ensure that the required storage conditions are maintained. They should be suitably secure, structurally sound and of sufficient capacity to allow safe storage and handling of the
medicinal products. Storage areas should be provided with adequate lighting and ventilation to enable all operations to be carried out accurately and safely.
3.2.2 作業場所非直接由批發運銷商營
運時，應具備書面委託合約。該 合約委託之作業場所應符合國內 法令之要求。
Where premises are not directly
operated by the wholesale distributor, a written contract should be in place.The contracted premises should be covered by a separate wholesale distribution authorisation if required by national legislation.
3.2.3 藥品應儲存於具適當標示並嚴格
管控進出人員之隔離區。任何替 代實體隔離之方式，如以電腦化 系統為主的電子隔離區域，應提 供同等的安全並進行確效。
Medicinal products should be stored in segregated areas which are clearly marked and have access restricted to authorised personnel. Any system replacing physical segregation, such as
electronic segregation based on a computerised system, should provide equivalent security and should be validated.
3.2.4 等待進一步決定處理或已由可銷
售品庫存移除之藥品，例如疑似 偽、禁藥及退回品，應實體或透 過同等效力之電子系統予以隔 離。應採用風險導向之方法評估 實體隔離及專用區的儲存要求。
至少偽、禁藥、過期藥品、回收 藥品、拒用藥品及未授權國內上 市的藥品必須要被實體隔離。
應清楚界定並適當管制此區域以 確保這些產品與可銷售品庫存區 分。
Products pending a decision as to their disposition or products that have been removed from saleable stock should be segregated either physically or through an equivalent electronic system. The requirement for physical segregation and storage in a dedicated area should be assessed using a risk based approach. At least, falsified medicinal products, expired products, recalled products, rejected products and medicinal
products not authorised for the internal market must always be physically segregated. The appropriate degree of security should be applied in these areas to ensure that such items remain
separate from saleable stock. These areas should be clearly identified.
3.2.5 應特別注意國內法令明定需特別
處理說明之藥品儲存。此類產品 (如麻醉藥及治療精神異常用藥)可 能需要特殊儲存條件(以及特殊許 可)。
Special attention should be paid to the storage of products with specific handling as specified in national legislation. Special storage conditions (and special authorisations) may be required for such products (e.g.
narcotics and psychotropic substances).
3.2.6 放射性物質及其他危害性之藥
品，以及具引起火災、爆炸等特 殊安全性風險的產品（如醫用氣 體、可燃物及可燃性液體與固 體），應儲存在一或多個符合國 內法令規範，安全性更高且具備 適當安全措施的專用區域。
Radioactive materials and other
hazardous products, as well as products presenting special safety risks of fire or explosion (e.g. medicinal gases,
combustibles, flammable liquids and solids), should be stored in one or more dedicated areas subject to national legislation and appropriate safety and security measures.
3.2.7 收貨區及出貨區應保護產品免於
受到天氣之影響。收貨區、出貨 區及儲存區應適當的隔離。應有 程序管制內銷及外銷產品。在收 貨過程中檢查貨物之收貨區應予
Receiving and dispatch bays should protect products from prevailing weather conditions. There should be adequate separation between the receipt and dispatch and storage areas. Procedures
以指定並具適當配備。 should be in place to maintain control of inbound/outbound goods. Reception areas where deliveries are examined following receipt should be designated and suitably equipped.
3.2.8 應防止未經授權之人員進入管制
作業場所的所有區域。預防措施 通常包括監測入侵者警報系統及 適當之入口管制。訪客應由經授 權的人員陪同。
Unauthorised access to all areas of the authorised premises should be
prevented. Prevention measures would usually include a monitored intruder alarm system and appropriate access control. Visitors should be accompanied by authorised personnel.
3.2.9 作業場所及儲存設施應保持乾淨
且不得有垃圾與灰塵，具備清潔 計畫、指令及紀錄，並作清潔以 避免成為污染源。
Premises and storage facilities should be clean and free from litter and dust.
Cleaning programmes, instructions and records should be in place. Cleaning should be conducted so as not to present a source of contamination.
3.2.10 作業場所的設計與配置應提供保
護，以防止昆蟲或其他動物的入 侵，且具備防蟲鼠的計畫，並維 持適當的防蟲鼠紀錄。
Premises should be designed and equipped so as to afford protection against the entry of insects, rodents or other animals. A preventive pest control programme should be in place.
Appropriate pest control records should be maintained.
3.2.11 員工的休息室、盥洗室及飲食區
應與儲存區適當的隔離。應禁止 在儲存區存放食物、飲料、香菸 或個人使用的藥品。
Rest, wash and refreshment rooms for employees should be adequately separated from the storage areas. The presence of food, drink, smoking material or medicinal products for personal use should be prohibited in the storage areas.
3.3.溫度及環境管制 (Temperature and Environment Control)
3.3.1 應具備適當的設備及程序以確認
藥品的儲存環境。需考量的環境 因素包括作業場所的溫度、濕 度、光線及清潔。
Suitable equipment and procedures should be in place to check the
environment where medicinal products are stored. Environmental factors to be considered include temperature, light, humidity and cleanliness of the
premises.
3.3.2 儲存區應在代表性的條件下於開 An initial temperature mapping exercise
始使用前進行初步的溫度測繪評 估。
溫度監測設備應依照測繪評估結 果設置，以確保監測設備是位於 歷經極端溫度波動的位置。溫度 測繪評估應依風險評估於有重大 改變時重複執行。若為數平方公 尺之小型常溫作業場所，應執行 潛在之風險評估(如冷或暖氣機)，
並依照其評估結果放置溫度監測 器。
should be carried out on the storage area before use, under representative
conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The
mapping exercise should be repeated for significant changes according to the results of a risk assessment exercise. For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g.
heater/air-conditioner) should be conducted and temperature monitors placed accordingly.
3.4 設備 (Equipment)
3.4.1 影響儲存及運銷藥品之所有設備
應依照符合其預定目的的標準設 計、設置、維護及清潔。操作具 重要功能的關鍵設備，應規劃進 行維護保養。
All equipment impacting on storage and distribution of medicinal products
should be designed, located, maintained and cleaned to a standard which suits its intended purpose. Planned maintenance should be in place for key equipment vital to the functionality of the
operation.
3.4.2 用於管制或監測藥品儲存環境之
設備，應依風險與可靠性評估結
果，在界定的時間間隔進行校
正。
Equipment used to control or to monitor the environment where the medicinal products are stored should be calibrated at defined intervals based on a risk and reliability assessment.
3.4.3 設備的校正應可被追溯到國家或
國際量測標準。設備應具備適當 的警報系統以在偏離預定儲存條 件時發出警報，且設定適當地警 報級別，並定期測試警報以確保 功能正常運作。
Calibration of equipment should be traceable to a national or international measurement standard. Appropriate alarm systems should be in place to provide alerts when there are excursions from predefined storage conditions.
Alarm levels should be appropriately set
and alarms should be regularly tested to ensure adequate functionality.
3.4.4 設備的維修、維護及校正作業不
得危害到藥品品質及完整性；在 設備發生故障時，應有程序確保 藥品維持其完整性。
Equipment repair, maintenance and calibration operations should be carried out in such a way that the quality and integrity of the medicinal products is not compromised. Procedures should be in place to ensure the integrity of medicinal products are maintained in the event of equipment failure.
3.4.5 應製作關鍵設備的維修、維護及
校正作業紀錄，並保存結果。關 鍵設備如冰庫、監測入侵者警報 與入口管制系統、冷藏庫、溫濕 度計或其他溫度與濕度記錄裝 置、空氣處理裝置及供應鏈內使 用的任何設備。
Adequate records of repair, maintenance and calibration activities for key
equipment should be made and the results should be retained. Key
equipment would include for example cold stores, monitored intruder alarm and access control systems,
refrigerators, thermo hygrometers, or other temperature and humidity
recording devices, air handling units and any equipment used in conjunction with the onward supply chain.
3.5 電腦化系統 (Computerised Systems)
3.5.1 使用電腦化系統前，系統應顯示
經適當的確效或確認，該系統能 準確、持續且再現性地達到預期 的結果。
Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and
reproducibly.
3.5.2 應可取得系統書面說明(適當時包
括圖解)，此說明應不斷更新。文 件應說明原則、目標、安全措 施、系統範圍與主要功能(電腦化 系統如何使用及與其他系統互動 的方式)。
A written, detailed description of the system should be available (including diagrams where appropriate). This should be kept up to date. The document should describe principles, objectives, security measures, system scope and main features, how the computerised system is used and the way it interacts with other systems.
3.5.3 僅有經授權的人員始得輸入或修
改數據。 Data should only be entered into the computerised system or amended by persons authorised to do so.
3.5.4 數據應以物理或電子方法確保其
不受意外或非授權的修改，儲存 之數據應定期檢查其可存取性。
數據應定期備份，備份數據應依 國內法令訂定保存時間，但至少 在分開及安全的地點保存 5 年。
Data should be secured by physical or electronic means and protected against accidental or unauthorised
modifications. Stored data should be checked periodically for accessibility.
Data should be protected by backing up at regular intervals. Backup data should be retained for the period stated in national legislation but at least 5 years at a separate and secure location.
3.5.5 電腦系統失效或當機時遵循的程
序應予以規範，應包括數據復原 系統。
Procedures to be followed if the system fails or breaks down should be defined.
This should include systems for the restoration of data.
3.6 驗證及確效 (Qualification and Validation)
3.6.1 批發運銷商應識別何種關鍵設備
驗證、關鍵流程確效可確保其安 裝及操作的正確性，驗證與確效 作業(如儲存、揀貨與包裝流程及 運輸)之範圍及程度應採文件化的 風險評估方式。
Wholesale distributors should identify what key equipment qualification and/or key process validation is necessary to ensure correct installation and operation.
The scope and extent of such
qualification and/or validation activities (such as storage, pick and pack
processes, transportation) should be determined using a documented risk assessment approach.
3.6.2 設備與流程在開始使用前及任何
重大變更後(如維修或維護)應分別 驗證或確效。
Equipment and processes should be respectively qualified and/or validated before commencing use and after any significant changes (e.g. repair or maintenance).
3.6.3 應準備確效與驗證報告，總結說
明獲得的結果及評論任何觀測到 的偏差；偏差應文件化並採取進 一步行動以矯正偏差及避免重複 發生，必要時應適用矯正預防措 施(CAPA)。合格確效的證明及流 程或設備的許可應由適當的人員 製作及核准。
Validation and qualification reports should be prepared summarising the results obtained and commenting on any observed deviations. Deviations from established procedures should be
documented and further actions decided to correct deviations and avoid their reoccurrence (corrective and preventive actions). The principles of CAPA should be applied where necessary. Evidence of
satisfactory validation and acceptance of a process or piece of equipment should be produced and approved by
appropriate personnel 第 4 章文件(Chapter 4 Documentation)
4.1 原則 (Principle)
優良文件是構成品質系統必要的 部分，書面文件應避免來自口頭 溝通的誤解，並容許藥品運銷相 關作業的追蹤，進行每項作業時 應記錄。
Good documentation constitutes an essential part of the quality system.
Written documentation should prevent errors from spoken communication and permits the tracking of relevant
operations during the distribution of medicinal products. Records should be made at the time each operation is undertaken.
4.2 General(一般規定)
4.2.1 文件包含以紙本或電子形式呈現
的所有書面程序、指令、合約、
紀錄及數據，文件應能立即取得/
取回。
Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in
electronic form. Documentation should be readily available/retrievable.
4.2.2 有關員工、申訴者或任何其他個
人資料之處理，應依國內法令之 規定存取。
With regard to the processing of personal data of employees, complainants or any other natural person, national legislation on the protection of individuals applies to the processing of personal data and to the free movement of such data.
4.2.3 關於批發運銷商活動範圍之文件
應使員工充分地理解，並以員工 可瞭解的語言書寫，書寫文件應 使用明確的語言且應無錯誤。
Documentation should be sufficiently comprehensive with respect to the scope of the wholesale distributor’s activities and in a language understood by
personnel. It should be written in clear, unambiguous language and be free from errors.
4.2.4 依規定，文件應由被指定之人員
核准、簽章並註明日期。文件本 身不得用手寫，但需要手寫填入 數據時，應有足夠的空間供此類 數據填入。
Documentation should be approved, signed and dated by designated persons, as required. It should not be
handwritten; although, where it is necessary, sufficient space should be provided for such entries.
4.2.5 文件中所進行的任何變更應簽章
並註明日期；該變更應允許讀取 Any alteration made in the
原來的資訊。適當時，更改理由
應記錄之。 documentation should be signed and dated; the alteration should permit the reading of the original information.
Where appropriate, the reason for the alteration should be recorded.
4.2.6 文件應依國內法令所規定的期間
保存，但至少 5 年。當個人資料 不為運銷活動目的所需時，應予 以刪除或匿名。
Documents should be retained for the period stated in national legislation but at least 5 years. Personal data should be deleted or anonymised as soon as their storage is no longer necessary for the purpose of distribution activities.
4.2.7 每位人員應可隨時取得與其執行
作業相關之文件。 Each employee should have ready access to all necessary documentation for the tasks executed.
4.2.8 應特別留意使用有效並經核准的
作業程序。文件應有明確的內 容，其標題、性質及目的應清楚 說明；文件應定期審查及更新，
版本管制應納入作業程序內；文 件經改版後，系統應有防止不慎 使用先前版本的功能，被取代或 廢棄的程序應從工作站移除及歸 檔。
Attention should be paid to using valid and approved procedures. Documents should have unambiguous content; title, nature and purpose should be clearly stated. Documents should be reviewed regularly and kept up to date. Version control should be applied to procedures.
After revision of a document a system should exist to prevent inadvertent use of the superseded version. Superseded or obsolete procedures should be removed from workstations and archived.
4.2.9 任何藥品接收、供應的交易紀錄
需以發票、送貨單、電腦或任何 其他形式保存。紀錄需至少包括 下列資料：日期、藥品名稱，及 接收與供應的數量，適當時應有 供應商、客戶及受託者之名稱、
地址，及批號、失效日期(依國內 法令之規定)。
適當時應有供應商、客戶與受託 者之名稱與地址，及批號與失效 日期(依國內法令之規定)。
記錄應與作業同時進行，且如為 手寫，字跡應清楚、易讀且不得 拭除。
Records must be kept either in the form of purchase/sales invoices, delivery slips, or on computer or any other form, for any transaction in medicinal
products received or supplied. Records must include at least the following information: date; name of the medicinal product; quantity received, supplied;
name and address of the supplier, customer, or consignee, as appropriate;
and batch number, expiry date, as required by national legislation.
Records are made contemporaneously and if handwritten, in clear, legible and indelible handwriting.
第 5 章作業 (Chapter 5 Operations)
5.1 原則 (Principle)
批發運銷商採取的所有作業應確 保藥品識別之完整，以及藥品的 批發運銷依照外包裝資料所提供 的說明執行。批發運銷商應盡可 能確保所有產品的來源，並採取 所有可用的方法減少偽、禁藥進 入合法供應鏈之風險。
All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of
falsified medicinal products entering the legal supply chain.
批發運銷商之運銷之所有藥品必 須取得中央衛生主管機關之許 可。所有關鍵作業應於品質系統 中適當文件化並充分描述。
All medicinal products distributed in the intended market by a wholesale
distributor must be appropriately authorised by the national authorities.
All key operations described below should be fully described in the quality system in appropriate documentation.
5.2 供應商之資格認可 (Qualification of Suppliers)
5.2.1 批發運銷商必須從符合國內法令
要求之供應者取得藥品。 Wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question.
5.2.2 從另一個批發運銷商取得藥品
時，接收端必須確認供應的批發 運銷商是否持有許可證，並遵守 藥品優良運銷規範的原則與指 引。
Where medicinal products are obtained from another wholesale distributor the receiving wholesale distributor must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold a licence.
5.2.3 在進行任何藥品採購之前，應對
供應商進行適當的資格認可及核 准。此作業應以程序管制，且其 結果應文件化並使用風險導向之 方法定期審閱。
Appropriate qualification and approval of suppliers should be performed prior to procurement of any medicinal
products. This should be controlled by a procedure and the results documented and periodically rechecked using a risk
based approach.
5.2.4 批發運銷商在與新的供應商締結
新合約時，應進行實質檢核(‘due diligence’ checks)以評估其供應藥 品的適當性、能力及可靠性，需 特別注意：
When entering into a new contract with new suppliers the wholesale distributor should carry out ‘due diligence’ checks in order to assess the suitability,
competence and reliability of the other party. Attention should be paid to:
i)供應商的聲譽或可靠性；
i) the reputation or reliability of the supplier;
ii)供應的藥品是否可能為偽、禁 藥；
ii) offers of medicinal products more likely to be falsified;
iii)大量供應通常僅能限量取得的
藥品； iii) large offers of medicinal products which are generally only available in limited quantities;
iv)供應商所經手產品之多樣性
iv) diversity of products handled by supplier;
v)價格超出範圍。
v) and out-of-range prices.
5.3 客戶的認可 (Qualification of Customers)
5.3.1 批發運銷商須確保其藥品只能供
應給符合國內法令要求之對象。 Wholesale distributors must ensure they supply medicinal products only to
persons who are themselves in
possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public or otherwise authorised to procure medicinal products from a distributor (for example medicinal products intended for clinical trials).
5.3.2 檢查及定期複查客戶持有藥品販
賣之許可文件及其他相關證明文 Checks and periodic rechecks may
