書 SOP

立合 GxP 之 SOP 予管行清可審指。

用

• 新驗系須行程→用
• 現非式程須正→用
• 審覓引缺程→用
• 變控觸 SOP 更→用
• 定審覓舊程容→用

入

• 必：SOP 蓋之程或系
• 必：管境（GMP、GLP、GCP、21 CFR Part 11、EU Annex 11）
• 必：標讀（從此 SOP 之角）
• 可：現非式程、工指、訓材
• 可：與此程接之關 SOP
• 可：致 SOP 立之審覓或管察

行

一：派文控元

# 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 有獨 ID 從機構文號規。 敗：無號規→先立：[TYPE]-[DEPT]-[3 位序]。

二：書意與範

### 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：意一二句。範清定界。 敗：範與現 SOP 疊→參現 SOP 於疊節，或改二者除疊。

三：定詞與縮

### 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：諸用縮與技詞皆定。 敗：詞含混或域特→參機構詞典或關管指得權威定。

四：派責

### 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：行節中諸行可溯責角。 敗：步無派角→孤責。SOP 批前派主。

五：書行節

此 SOP 核。書步步指：

### 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 書則：

• 每步以行詞始（驗、錄、入、批、通）
• 詳足訓員可從而無解
• 含決點附各路標
• 參確切表名、系幕、工識
• 含止點：工須停候批或驗

得：訓而不熟特程之人可從此步行正。 敗：題專謂程含混→加詳或斷步為副步。SOP 含混為復現審覓。

六：加參、附件、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：諸所參文用可訪、修史始於 1.0。 敗：所參文未存→建之、或移參並錄 SOP 審中之隙。

七：路審與批

### 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 由題專審、由質批方生效。 敗：批流延→效日須推。SOP 無完批不可生效。

驗

• 文 ID 從機構號規
• 意特且簡（1-2 句）
• 範清定範內外界
• 諸縮與技詞皆定
• 責節各角配步
• 行步以行詞始且詳足從無解
• 決點附各路標
• 偏理已定
• 諸所參文存可訪
• 修史完從 1.0
• 批簽含作者、審者、批者
• 定審程已定

忌

• 過泛：「確數質」非行步。「驗 Form-001 諸 15 欄填且於 Appendix A 範內」乃行步
• 過詳：含每誤之排疾使 SOP 不可讀。複排引別工指
• 無偏理：每 SOP 須定不能從時何為。偏默示無偏可能
• 訓前生效：諸用未訓而 SOP 生效→即合隙
• 孤 SOP：永不審之 SOP 舊不靠。設審日跡於文控系

參

• design-compliance-architecture — 辨何系與程須 SOP
• manage-change-control — 程變時觸 SOP 更
• design-training-program — 確用於新更 SOP 受訓
• conduct-gxp-audit — 審評 SOP 足與從
• write-validation-documentation — SOP 與驗文共批流