write-standard-operating-procedure（编写标准操作程序）

Write Standard Operating Procedure

Create a GxP-compliant Standard Operating Procedure that provides clear, auditable instructions for regulated activities.

When to Use

• A new validated system requires operational procedures
• Existing procedures need formalisation into SOP format
• An audit finding cites missing or inadequate procedures
• A change control triggers SOP updates
• Periodic review identifies outdated procedural content

Inputs

• Required: Process or system the SOP covers
• Required: Regulatory context (GMP, GLP, GCP, 21 CFR Part 11, EU Annex 11)
• Required: Target audience (roles that will follow this SOP)
• Optional: Existing informal procedures, work instructions, or training materials
• Optional: Related SOPs that interface with this procedure
• Optional: Audit findings or regulatory observations driving the SOP creation

Procedure

Step 1: Assign Document Control Metadata

# 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"] |

Expected: Every SOP has a unique ID following the organisation's document numbering convention. On failure: If no numbering convention exists, establish one before proceeding: [TYPE]-[DEPT]-[3-digit sequential].

Step 2: Write the Purpose and Scope

### 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]

Expected: Purpose is one to two sentences. Scope clearly defines boundaries. On failure: If scope overlaps with an existing SOP, either reference the existing SOP for the overlapping section or revise both SOPs to eliminate the overlap.

Step 3: Define Terms and Abbreviations

### 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] |

Expected: Every abbreviation and technical term used in the SOP is defined. On failure: If a term is ambiguous or domain-specific, consult the organisation's glossary or the relevant regulatory guidance for the authoritative definition.

Step 4: Assign Responsibilities

### 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 |

Expected: Every action in the Procedure section can be traced to a responsible role. On failure: If a procedural step has no assigned role, it is an orphaned responsibility. Assign an owner before the SOP is approved.

Step 5: Write the Procedure Section

This is the core of the SOP. Write step-by-step instructions:

### 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.

Writing rules for GxP SOPs:

• Start each step with an action verb (verify, record, enter, approve, notify)
• Be specific enough to be followed by a trained operator without interpretation
• Include decision points with clear criteria for each path
• Reference exact form names, system screens, or tool identifiers
• Include hold points where work must stop pending approval or verification

Expected: A trained person unfamiliar with the specific process could follow these steps correctly. On failure: If subject matter experts say the procedure is ambiguous, add detail or break the step into sub-steps. Ambiguity in SOPs is a recurring audit finding.

Step 6: Add References, Attachments, and Revision History

### 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 |

Expected: All referenced documents are accessible to users, and revision history starts from version 1.0. On failure: If referenced documents do not exist yet, either create them or remove the reference and note the gap in the SOP review.

Step 7: Route for Review and Approval

### 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

Expected: SOP is reviewed by a subject matter expert and approved by quality before becoming effective. On failure: If the approval workflow is delayed, the effective date must be pushed back. An SOP cannot be effective without completed approvals.

Validation

• Document ID follows the organisation's numbering convention
• Purpose is specific and concise (1-2 sentences)
• Scope clearly defines in-scope and out-of-scope boundaries
• All abbreviations and technical terms are defined
• Every role in the Responsibilities section maps to procedure steps
• Procedure steps start with action verbs and are specific enough to follow without interpretation
• Decision points have clear criteria for each path
• Deviation handling is defined
• All referenced documents exist and are accessible
• Revision history is complete from version 1.0
• Approval signatures include author, reviewer, and approver
• Periodic review schedule is defined

Common Pitfalls

• Too vague: "Ensure data quality" is not a procedural step. "Verify that all 15 fields in Form-001 are populated and within range per Appendix A" is.
• Too detailed: Including troubleshooting for every possible error makes the SOP unreadable. Reference a separate work instruction for complex troubleshooting.
• No deviation handling: Every SOP must define what to do when the procedure cannot be followed as written. Silence on deviations implies no deviations are possible.
• Effective before training: An SOP that is effective before all users are trained creates an immediate compliance gap.
• Orphaned SOPs: SOPs that are never reviewed become outdated and unreliable. Set review dates and track them in the document control system.

Related Skills

• design-compliance-architecture — identifies which systems and processes need SOPs
• manage-change-control — triggers SOP updates when processes change
• design-training-program — ensures users are trained on new and updated SOPs
• conduct-gxp-audit — audits assess SOP adequacy and adherence
• write-validation-documentation — SOPs and validation docs share approval workflows