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Periodic review identifies outdated procedural content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

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

write-standard-operating-procedure