What is meant by Good Documentation Practice?

[中譯] 什麼是優良文件作業規範 (GDP)？

Principles of GMP-compliant documentation

[中譯] 符合 GMP 規範的文件紀錄原則

Documentation fulfils several key functions within the GMP environment and is an indispensable component of quality assurance.
[中譯] 在 GMP 環境中，文件記錄具備多項關鍵功能，是品質保證中不可或缺的組成部分。

A primary objective is to ensure product quality. GMP-compliant documentation demonstrates that a medicinal product has been manufactured in accordance with the approved specifications and legal requirements. Without this evidence, neither compliance with regulatory requirements could be verified nor the quality of a product substantiated.
[中譯] 首要目標是確保產品品質。符合 GMP 規範的文件紀錄能證明藥品是按照核准的規格及法律要求進行製造的。若無此證據，不僅無法驗證其是否符合法規要求，亦無法證實產品的品質。

Another key aspect is traceability. The documented steps must make the entire manufacturing process of a batch traceable - from the raw materials used and process parameters right through to the personnel involved. This traceability is particularly crucial in the event of quality issues or product recalls. It enables the systematic monitoring, control and evaluation of all quality-relevant processes. The EU GMP guidelines therefore describe documentation as an essential component of the quality system.
[中譯] 另一個關鍵層面是可追溯性。記錄下的步驟必須讓整個批次的製造流程皆可追溯——從所使用的原物料、製程參數，一直到參與的相關人員。在發生品質異常或產品召回時，此可追溯性尤為關鍵。它使得所有與品質相關的流程得以被系統化地監控、控制及評估。因此，歐盟 GMP 指南將文件管制描述為品質系統的重要環節。

Legal protection also plays an important role. Documents serve as evidence for regulatory authorities. In the event of a dispute, only complete documentation can prove that processes were carried out correctly.
[中譯] 法律保護也扮演了重要角色。文件是提供給法規主管機關的證據。在發生爭議時，唯有完整的文件紀錄能證明流程已被正確執行。

Another key point is data integrity. The ALCOA principle requires that data must be attributable, legible, timely, original and accurate. GMP-compliant documentation ensures that these requirements are met.
[中譯] 另一個重點是數據完整性 (Data Integrity)。ALCOA 原則要求數據必須具備可歸屬性、易讀性、同時性、原始性及準確性。符合 GMP 規範的文件紀錄能確保這些要求被妥善履行。

Furthermore, documentation supports knowledge management by enabling processes to be documented, made reproducible and continuously improved.
[中譯] 此外，文件記錄透過將流程建檔，使其具備可重現性並得支持持續改善，進而支援組織的知識管理。

In summary, documentation is necessary for quality, traceability, legal certainty, data integrity and organisational learning.
[中譯] 總結來說，文件記錄對於品質、可追溯性、法律確定性、數據完整性以及組織學習都是必不可少的。

Where do the specifications/requirements come from?

[中譯] 這些規範與要求源自何處？

The requirements for GMP-compliant documentation stem from various regulatory and organisational sources. The most important foundations are statutory regulations. In Germany, these are:
[中譯] 符合 GMP 規範的文件要求源自多個法規與組織來源。最重要的基礎是法定規範。在德國，這些法規包含：

• the German Medicines Act (AMG)
  [中譯] 德國藥事法 (AMG)
• the Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV)
  [中譯] 藥品與活性物質製造條例 (AMWHV)

These oblige companies to introduce a documentation system and define fundamental requirements such as completeness, legibility and protection against tampering.
[中譯] 這些法規強制企業導入文件系統，並界定了如完整性、易讀性以及防篡改等基本要求。

The overarching, Europe-wide guideline is the EU GMP Guide. This specifies the legal requirements and describes in detail the documentation requirements, e.g. in Chapter 4.
[中譯] 涵蓋全歐洲的總體指南則是歐盟 GMP 指南。它明定了法律要求，並在第四章等處詳細描述了文件記錄的規範。

In addition, national authorities such as the German ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten - Central Agency of the Federal States for Health Protection in relation to Medicinal Products and Medical Devices) provide practical guidance on interpretation in the form of procedural instructions and aide-mémoires.
[中譯] 此外，各國主管機關如德國的 ZLG（負責藥品及醫療器材健康保護之聯邦州中央機構），也以程序說明和備忘錄的形式提供實務上的解釋指導。

At an international level, FDA regulations play a significant role, particularly 21 CFR Part 211. These contain detailed requirements for production controls and reports. In addition, there are international guidelines, such as those from the ICH (International Council for Harmonisation), which define harmonised standards worldwide.
[中譯] 在國際層面上，FDA 法規扮演了重要角色，特別是 21 CFR Part 211。這些法規包含了生產管控與報告的詳細要求。另外還有如 ICH（國際醫藥法規協和會）等國際指南，定義了全球調和的標準。

Finally, specific requirements also originate from internal company sources, in particular:
[中譯] 最後，特定的要求也源自於公司內部資源，特別是：

• Marketing authorisation dossiers
  [中譯] 上市許可申請卷宗
• Development data
  [中譯] 開發數據
• Specifications
  [中譯] 規格標準

This results in an interplay of legal, regulatory and internal requirements.
[中譯] 這造就了法律、法規與內部要求之間的交互作用。

What information/requirements are necessary?

[中譯] 需要哪些資訊/要求？

The documentation comprises various document types and contents defined in the EU GMP guidelines.
[中譯] 文件系統包含歐盟 GMP 指南所定義的各種類型及內容。

The most important document types include:
[中譯] 最重要的文件類型包括：

• Instructions (e.g. manufacturing instructions)
  [中譯] 指導書（例如製造管制標準書）
• SOPs (Standard Operating Procedures)
  [中譯] 標準作業程序 (SOP)
• Specifications
  [中譯] 規格標準
• Records (e.g. manufacturing records)
  [中譯] 紀錄（例如批次製造紀錄）
• Reports and certificates of analysis
  [中譯] 分析報告與檢驗證明書 (COA)

Manufacturing instructions, which specify how a product is manufactured, play a central role. These must be drawn up in advance, approved, checked and strictly adhered to. Equally important are manufacturing records, in which the actual execution is documented. A complete record is required for each batch, including all deviations. Raw data is another important component. It serves as the basis for all analyses and must be fully retained or stored.
[中譯] 明確規定產品如何被製造的製造管制標準書扮演著核心角色。這些指導書必須預先制定、獲得批准、檢查並被嚴格遵守。同樣重要的是記錄實際執行狀況的製造紀錄。每個批次都必須有一份完整的紀錄，其中包含所有的偏差 (Deviation)。原始數據 (Raw data) 是另一個重要組成。它是所有分析的基礎，必須被完整保留或儲存。

The documentation must also include the following:
[中譯] 文件紀錄還必須包含以下內容：

• Process parameters and target values
  [中譯] 製程參數與目標值
• Tolerance limits
  [中譯] 容許誤差限制
• Results of in-process controls
  [中譯] 製程中管制 (IPC) 結果
• Deviations and their assessment
  [中譯] 偏差及其評估
• Responsibilities and signatures
  [中譯] 權責單位及簽名

Missing information - such as tolerance limits - can lead to serious complaints.
[中譯] 遺漏任何資訊——例如公差限制——都可能導致嚴重的法規缺失。

In addition, details regarding test methods and validation or stability data are required. Approvals and releases must also be documented.
[中譯] 此外，關於檢測方法、確效 (Validation) 或安定性數據的細節都是必需的。核准與放行程序也必須被完整記錄。

Finally, retention requirements must be observed: documents must be archived in full and for defined periods.
[中譯] 最後，必須遵守保存要求：文件必須被完整歸檔，並保存規定的期限。

How is documentation carried out and what must be observed?

[中譯] 如何執行文件紀錄，以及必須注意哪些事項？

The practical implementation of documentation is subject to the rules of good documentation practice.
[中譯] 文件紀錄的實務執行須受到優良文件作業規範 (GDP) 規則的約束。

Key requirements are:
[中譯] 關鍵要求包含：

• Legibility
  [中譯] 易讀性
• Traceability
  [中譯] 可追溯性
• Completeness
  [中譯] 完整性
• Timely recording
  [中譯] 同步記錄 (及時性)
• Immutability
  [中譯] 不可篡改性

These requirements ensure that data is reliable and verifiable.
[中譯] 這些要求確保了數據的可靠性與可驗證性。

Documentation may be carried out in paper form, electronically or in a hybrid format. In all cases, suitable control mechanisms must be in place. Additional requirements apply to electronic systems, such as:
[中譯] 文件記錄可以紙本、電子或混合形式進行。在所有情況下，都必須具備適當的管控機制。對電子系統更適用以下額外要求：

• Validation of the systems
  [中譯] 電腦化系統確效 (CSV)
• Protection against data loss
  [中譯] 防範數據遺失
• Ensuring legibility
  [中譯] 確保易讀性
• Use of electronic signatures
  [中譯] 使用電子簽章

The creation of documents is also regulated:
[中譯] 文件的建立同樣受到規範：

• Clear and unambiguous content
  [中譯] 內容清晰且無歧義
• Approval by authorised persons
  [中譯] 授權人員核准
• Dating and versioning
  [中譯] 標示日期與版本控制
• Regular updating
  [中譯] 定期更新

The following aspects are crucial during implementation:
[中譯] 在執行過程中，以下幾個層面至關重要：

• Strict adherence to instructions
  [中譯] 嚴格遵守指導書
• Immediate and complete documentation
  [中譯] 立即且完整的紀錄
• Documentation of all deviations
  [中譯] 記錄所有的偏差事件
• No subsequent, non-traceable changes
  [中譯] 嚴禁事後進行無法追溯的竄改

Entries must not be rendered illegible, and changes must remain transparent.
[中譯] 登錄的內容不得被塗改至無法辨識，且修改過程必須保持透明。

The retention of documents requires:
[中譯] 文件的保存要求：

• Secure archiving
  [中譯] 安全歸檔
• Clear allocation
  [中譯] 配置清晰
• Compliance with defined timeframes
  [中譯] 遵守法定的保存期限

Conclusion

[中譯] 結論

In the GMP environment, documentation is a central component of quality assurance and regulatory compliance. It serves not only to provide evidence, but also for process control, risk minimisation and knowledge retention.
[中譯] 在 GMP 環境中，文件紀錄是品質保證與法規遵循的核心元件。它不僅提供證據，更用於製程管控、風險最小化及知識保存。

The requirements arise from a complex interplay of laws, guidelines and internal regulations. Content and implementation are clearly regulated and must be strictly adhered to.
[中譯] 這些要求源於法律、指南與內部規範的複雜交互作用。文件的內容與執行皆有明確規定，且必須被嚴格遵守。

Errors or gaps in documentation can have serious consequences, such as complaints from regulatory authorities or the loss of marketing authorisations. Therefore, the following principle applies in the pharmaceutical sector: 'What is not documented is considered not to be done.'
[中譯] 文件中的錯誤或遺漏將導致嚴重的後果，例如法規單位的客訴或失去上市許可。因此，製藥界遵循著以下鐵則： 「沒有記錄，就等於沒有做。」