原則（PRINCIPLE）
優良文件是構成品質保證系統必要的部 分，而且是符合/遵循GMP要求之操作的 關鍵。所使用之各種類型的文件與檔案資 料，應在製造廠的品質管理系統中充分地 界定。文件可能以多種形式存在，包括以 紙本的、電子的或照像的資料。文件製作 系統的主要目的，必須建立、管制、監控 與記錄所有活動，該等活動會直接或間接 影響藥物產品品質的所有層面。品質管理 系統除提供各種流程以及任何觀察之評 估的充分紀錄外，還應包含足夠的指導細 節，以利共同理解這些要求，並使這些要 求之持續應用得以證明。
Good documentation constitutes an essential part of the quality assurance system and is key to operating in
compliance with GMP requirements. The various types of documents and media used should be fully defined in the
manufacturer's Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. The main objective of the system of documentation utilized must be to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality of medicinal products. The Quality Management System should include sufficient instructional detail to facilitate a common understanding of the
requirements, in addition to providing for sufficient recording of the various
processes and evaluation of any
observations, so that ongoing application of the requirements may be demonstrated.
用於管理與記錄GMP符合性之文件有兩 種主要類型，包括指令（指導、要求）與 紀錄/報告。應依適當的優良文件製作規 範製作相關類型的文件。
There are two primary types of
documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports.
Appropriate good documentation practice should be applied with respect to the type of document.
應實施適當的管制，以確保文件的正確 性、完整性、可得性與可讀性。指導文件
應無錯誤並且可以以書面取得。「書面」
意指在檔案資料上所記錄或文件化的數 據，藉以成為可讀取的形式。
Suitable controls should be implemented to ensure the accuracy, integrity, availability and legibility of documents. Instruction documents should be free from errors and available in writing. The term ‘written’
means recorded, or documented on media from which data may be rendered in a human readable form.
所需要的 GMP 文件（按類型）
【REQUIRED GMP DOCUMENTATION (BY TYPE)】
工廠基本資料（Site Master File）：描述 製造廠之GMP相關活動的文件。
Site Master File: A document describing the GMP related activities of the
manufacturer.
指令（指導或要求）類型【Instructions (directions, or requirements) type】：
規格：詳細描述在製造期間所使用的或所 取得的原物料或產品必須符合的要求。規 格是作為品質評估的基礎。
Specifications: Describe in detail the requirements with which the products or materials used or obtained during
manufacture have to conform. They serve as a basis for quality evaluation.
製造配方、操作/加工、分/包裝與檢驗的 指令： 提供所要使用之所有原料、設備 與電腦化系統（如有）的細節，並且規定 所有操作/加工、分/包裝、取樣與檢驗的 指導。所要使用的製程中管制與製程分析
技術，連同允收標準（合適時），應該加
以規定。
Manufacturing Formulae, Processing, Packaging and Testing Instructions:
Provide detail all the starting materials, equipment and computerised systems (if any) to be used and specify all processing, packaging, sampling and testing
instructions. In-process controls and process analytical technologies to be employed should be specified where relevant, together with acceptance criteria.
程序：（或稱為標準作業程序，簡稱
SOPs），對於執行某些操作/作業給予指
導。
Procedures: (Otherwise known as
Standard Operating Procedures, or SOPs), give directions for performing certain operations.
計畫書：對於執行與記錄某些需謹慎操作 /作業給予指令。
Protocols: Give instructions for
performing and recording certain discreet operations.
技術協議：委託者與受託者之間對於委外 活動的協議。
Technical Agreements: Are agreed between contract givers and acceptors for outsourced activities.
紀錄/報告類型（Record/Report type）：
紀錄：提供所採取之各種行動的證據，以 證明遵循指令，例如：活動、事件、調查 及在製造批次的情況下，每一個產品批次 的歷史，包含其運銷在內。紀錄包括使用 於產生其他紀錄的原始數據。對於電子紀 錄，受管制的使用者應界定哪些數據要當 作原始數據使用。至少，應將所有據以決 定品質的數據，界定為原始數據。
Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution.
Records include the raw data which is used to generate other records. For electronic records regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data.
分析證明書：提供關於產品或原物料樣品
之檢驗結果的摘要1，連同對所陳述之規
格符合性的評估。
Certificates of Analysis: Provide a summary of testing results on samples of products or materials1 together with the evaluation for compliance to a stated specification.
報告：將特定的運用、計畫或調查的執行 /處理，連同結果、結論與建議加以文件 化。
Reports: Document the conduct of particular exercises, projects or investigations, together with results, conclusions and recommendations.
文件的產生與管制（GENERATION AND CONTROL OF DOCUMENTATION）
4.1 應界定所有文件的類型並遵守之。此等要
4.1 All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place.
Many documents (instructions and/or records) may exist in hybrid forms, i.e.
some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for
electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.
4.2 文件應經謹慎設計、製作、審核及分發。
合適時，該等文件應符合產品規格檔案、
製造與上市許可文件的相關部分。來自正 本之工作文件的複製，不得因複製過程導 入任何錯誤。
4.2 Documents should be designed, prepared, reviewed, and distributed with care. They should comply with the relevant parts of Product Specification Files, Manufacturing and Marketing Authorisation dossiers, as appropriate. The reproduction of working documents from master documents should not allow any error to be introduced through the reproduction process.
4.3 含指令的文件應由適當且經授權的人員 核定、簽章並註明日期。文件應具有明確 之內容且應為獨特可確認的。生效日期應 加以界定。
4.3 Documents containing instructions should be approved, signed and dated by
appropriate and authorised persons.
Documents should have unambiguous contents and be uniquely identifiable. The effective date should be defined.
4.4 含指令的文件，應以有條理的方式編排且 易於核對。文件之格式與語文應配合其預 定的用途。標準作業程序、作業指令與方 法皆應以強制性的格式書寫。
4.4 Documents containing instructions should be laid out in an orderly fashion and be easy to check. The style and language of documents should fit with their intended use. Standard Operating Procedures, Work Instructions and Methods should be written in an imperative mandatory style.
4.5 品質管理系統內的文件應定期檢討且應 保持其最新版本。當一份文件經修訂後，
應有一系統運作，以防止作廢文件被誤 用。
4.5 Documents within the Quality
Management System should be regularly reviewed and kept up-to-date. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents.
4.6 文件本身不得用手寫，但需手寫填入數據 時，應有足夠的空間供此類數據的填入。
4.6 Documents should not be hand-written;
although, where documents require the entry of data, sufficient space should be provided for such entries.
優良文件製作規範（GOOD DOCUMENTATION PRACTICES）
4.7 手寫填入資料時，應以清晰、可讀且擦不 掉的方式為之。
4.7 Handwritten entries should be made in clear, legible, indelible way.
4.8 採取每項行動時，即應記錄。因此，與藥 品製造有關的所有重要活動皆可追溯。
4.8 Records should be made or completed at the time each action is taken and in such a way that all significant activities
concerning the manufacture of medicinal products are traceable.
4.9 文件上對於填入項目所做的任何更改應 予簽章並註明日期；該更改應允許讀取原 來的資訊。合適時，更改理由應記錄之。
4.9 Any alteration made to the entry on a document 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.
文件保存（RETENTION OF DOCUMENTS）
4.10 應清楚界定與每個製造活動相關的紀錄 及其存放處。必須具備安全管制，以確保 在整個保存期間紀錄的完整性，且合適時 必須進行確效。
4.10 It should be clearly defined which record is related to each manufacturing activity and where this record is located. Secure controls must be in place to ensure the integrity of the record throughout the retention period and validated where appropriate.
4.11 對於批次文件，特定的要求適用於必須保 存到該批次之末效日期後一年，或保存到 在該批次經由被授權人認定後至少五 年，兩者取其較長者。對於研究用藥品，
批次文件必須保存到所使用之該批次的 最終臨床試驗完成後或試驗正式中止後 至少五年。對於文件之保存的其它要求，
可能敘述於特定類型產品（例如，新興治 療藥品）之相關法規中，並規定某些文件 應採用較長的保存期限。
4.11 Specific requirements apply to batch documentation which must be kept for one year after expiry of the batch to which it relates or at least five years after
certification of the batch by the Authorised Person, whichever is the longer. For investigational medicinal products, the batch documentation must be kept for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. Other requirements for retention of
documentation may be described in legislation in relation to specific types of product (e.g. Advanced Therapy Medicinal Products) and specify that longer retention periods be applied to certain documents.
4.12 對於其他類型的文件，保存期限將依其作 業活動而定。上市許可資訊的關鍵文件，
包含原始數據（例如：與確效或安定性相 關者）在內，應在該上市許可仍然有效的 期間加以保存。當數據已由一套完整的新 數據取代時，將某些文件（例如，支持確 效報告或安定性報告的原始數據）廢除，
視為可接受的。對此文件廢除的正當性證 明應加以文件化，且應考慮批次文件保存 的要求；例如，在製程確效數據的情況 中，其所伴隨的原始數據應予保存，其期 限應至少與基於該確效作業所支持放行 的所有批次紀錄的期間相同。
4.12 For other types of documentation, the retention period will depend on the
business activity which the documentation supports. Critical documentation, including raw data (for example relating to validation or stability), which supports information in the Marketing Authorisation should be retained whilst the authorization remains in force. It may be considered acceptable to retire certain documentation (e.g. raw data supporting validation reports or stability reports) where the data has been
superseded by a full set of new data.
Justification for this should be documented and should take into account the
requirements for retention of batch
documentation; for example, in the case of process validation data, the accompanying raw data should be retained for a period at least as long as the records for all batches whose release has been supported on the basis of that validation exercise.
下節提供所需文件的一些實例。為確保產 品品質與病患安全，品質管理系統應敘明 所需要的所有文件。
The following section gives some examples of required documents. The quality management system should describe all documents required to ensure product quality and patient safety.
規格（SPECIFICATIONS）
4.13 原料、包裝材料及最終產品，應有適當經 核准且註明日期的規格。
4.13 There should be appropriately authorised and dated specifications for starting and packaging materials, and finished products.
原料及包裝材料的規格（Specifications for starting and packaging materials）
4.14 原料及直接包裝或印刷包裝材料之規 格，如果可行，應包括下列項目:
4.14 Specifications for starting and primary or printed packaging materials should include or provide reference to, if applicable:
a) 原物料的描述，包括： a) A description of the materials, including:
- 指定的名稱及內部的參考代碼； - The designated name and the internal code reference;
- 藥典個論的參考資料（如有時）； - The reference, if any, to a pharmacopoeial monograph;
- 認可的供應商，及其原始的生產者
（如可能時）；
- The approved suppliers and, if reasonable, the original producer of the material;
- 印刷材料的樣本； - A specimen of printed materials;
b) 抽樣、檢驗的指示； b) Directions for sampling and testing;
c) 具有合格標準範圍之定性及定量的要 求；
c) Qualitative and quantitative
requirements with acceptance limits;
d) 儲存的條件及注意事項； d) Storage conditions and precautions;
e) 再驗前的最長儲存期間。 e) The maximum period of storage before
e) 再驗前的最長儲存期間。 e) The maximum period of storage before