書標準作業程序

立合 GxP 之標準作業程序（SOP），予監管活動以明、可審之囑。

用時

• 新已驗系需作業程
• 現非式之程需化為 SOP
• 審發現引缺或不足之程
• 變控觸 SOP 更
• 周期察識陳之程內

入

• 必要：SOP 涵之過或系
• 必要：監管脈絡（GMP、GLP、GCP、21 CFR Part 11、EU Annex 11）
• 必要：目用者（將從此 SOP 之角）
• 可選：現非式程、工囑、或訓材
• 可選：與此程界之相關 SOP
• 可選：致 SOP 立之審發現或監管察

法

第一步：授文控元

# Standard Operating Procedure
## Document ID: SOP-[DEPT]-[NNN]
## Title: [Descriptive Title of the Procedure]

| Field | Value |
|-------|-------|
| Document ID | SOP-[DEPT]-[NNN] |
| Version | 1.0 |
| Effective Date | [YYYY-MM-DD] |
| Review Date | [YYYY-MM-DD + review period] |
| Department | [Department name] |
| Author | [Name, Title] |
| Reviewer | [Name, Title] |
| Approver | [Name, Title] |
| Classification | [GxP-Critical / GxP-Supporting] |
| Supersedes | [Previous SOP ID or "N/A — New"] |

得：每 SOP 有唯 ID 從組之文號約。 敗則：無號約者，前進前立之：[TYPE]-[DEPT]-[3 位序]。

第二步：書其用與其範

### 1. Purpose
This SOP defines the procedure for [specific activity] to ensure [regulatory objective].

### 2. Scope
**In scope:**
- [System, process, or activity covered]
- [Applicable departments or roles]
- [Specific regulatory requirements addressed]

**Out of scope:**
- [Related activities covered by other SOPs — reference them]
- [Systems or departments not covered]

得：用為一二句。範明定界。 敗則：範與現 SOP 重者，或為重段引現 SOP，或修兩 SOP 以除重。

第三步：定詞與略

### 3. Definitions and Abbreviations

| Term | Definition |
|------|-----------|
| ALCOA+ | Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available |
| CCB | Change Control Board |
| GxP | Good [Manufacturing/Laboratory/Clinical] Practice — umbrella for all regulated quality standards |
| SOP | Standard Operating Procedure |
| [Add terms specific to this SOP] | [Definition] |

得：SOP 中每略與技詞皆已定。 敗則：詞歧或域特者，查組之詞表或相關監管囑為權威定。

第四步：授責

### 4. Responsibilities

| Role | Responsibilities |
|------|-----------------|
| System Owner | Ensure SOP compliance, approve changes, conduct periodic review |
| System Administrator | Execute daily operations per this SOP, report deviations |
| Quality Assurance | Review SOP for regulatory compliance, approve new versions |
| End Users | Follow procedures as written, report issues to system administrator |
| Training Coordinator | Ensure all affected personnel are trained before SOP effective date |

得：程段每行皆可溯至責角。 敗則：程步無授角者，為孤責。SOP 批前授屬。

第五步：書程段

此為 SOP 核。書逐步囑：

### 5. Procedure

#### 5.1 [First Major Activity]
1. [Action verb] [specific instruction]. Reference: [form, system screen, tool].
2. [Action verb] [specific instruction].
   - If [condition], then [action].
   - If [alternative condition], then [alternative action].
3. [Action verb] [specific instruction].
4. Record the result in [form/system/log].

#### 5.2 [Second Major Activity]
1. [Action verb] [specific instruction].
2. Verify [specific criterion].
3. If verification fails, initiate [deviation procedure — reference SOP-XXX].

#### 5.3 Deviation Handling
1. If any step cannot be performed as written, STOP and document the deviation.
2. Notify [role] within [timeframe].
3. Complete Deviation Form [form reference].
4. Do not proceed until [role] provides disposition.

GxP SOP 之書則：

• 每步以行動詞始（驗、錄、入、批、通）
• 具足以使訓員無解而從
• 含決點附每路明準
• 引精表名、系幕、或具識
• 含止點，工須止待批或驗

得：訓人不熟此特過者可從之而正。 敗則：家謂程歧者，加詳或分步為子步。SOP 之歧為常審發現。

第六步：加參、附、修史

### 6. References
| Document ID | Title |
|-------------|-------|
| SOP-QA-001 | Document Control |
| SOP-IT-015 | User Access Management |
| [Regulation reference] | [e.g., 21 CFR Part 11] |

### 7. Attachments
| Attachment | Description |
|-----------|-------------|
| Form-001 | [Form name and purpose] |
| Template-001 | [Template name and purpose] |

### 8. Revision History
| Version | Date | Author | Change Description |
|---------|------|--------|--------------------|
| 1.0 | [Date] | [Name] | Initial release |

得：諸引文於用者可達，修史自版 1.0 始。 敗則：引文未存者，立之或去其引並注 SOP 察之缺。

第七步：路察與批

### Approval Signatures

| Role | Name | Signature | Date |
|------|------|-----------|------|
| Author | [Name] | | |
| Technical Reviewer | [Name] | | |
| QA Reviewer | [Name] | | |
| Approver (Department Head) | [Name] | | |

### Training Requirement
All personnel listed in Section 4 must complete training on this SOP before the effective date. Training must be documented in the training management system.

### Periodic Review
This SOP must be reviewed at least every [2 years / annually] or when triggered by:
- Change control affecting the covered process or system
- Audit finding related to the covered process
- Regulatory guidance update affecting the covered requirements

得：SOP 為家察，質前批方生效。 敗則：批流延者，效日須推。SOP 無完批不能生效。

驗

• 文 ID 從組之號約
• 用具且簡（1-2 句）
• 範明定內外界
• 諸略與技詞皆定
• 責段中每角映程步
• 程步以行動詞始且具足以無解而從
• 決點各路有明準
• 偏差處已定
• 諸引文存且可達
• 修史自版 1.0 完
• 批簽含作、察、批者
• 周期察程已定

陷

• 過糊：「確數質」非程步。「驗 Form-001 之 15 域皆充且依 Appendix A 於範」乃。
• 過詳：含每訛之排診使 SOP 不可讀。複排診引別工囑
• 無偏差處：每 SOP 必定程不可從時何為。偏差默謂無偏差可
• 訓前生效：SOP 諸用者訓前生效立致合差
• 孤 SOP：未察之 SOP 陳不可信。設察日且於文控系追之

參

• design-compliance-architecture — 識何系與過需 SOP
• manage-change-control — 過變時觸 SOP 更
• design-training-program — 確用者於新與更 SOP 已訓
• conduct-gxp-audit — 審評 SOP 之足與從
• write-validation-documentation — SOP 與驗文共批流