Published on 07/12/2025
Defining Scope in a Pharma VMP: What to Include & Exclude for Regulatory Clarity
The Validation Master Plan (VMP) is a cornerstone document in pharmaceutical quality systems. It defines the approach, strategy, and schedule of validation activities. A critical element of the VMP — often scrutinized during audits — is the definition of its scope and boundaries.
Clearly delineating what is included and excluded from validation, and why, ensures the VMP is not only compliant but also practical and risk-based. This article provides a comprehensive guide to establishing a robust VMP scope that aligns with FDA, EMA, ICH, and WHO expectations.
1. Why Defining Scope Is Critical
- Prevents ambiguity about what systems and processes require validation
- Aligns teams across QA, engineering, manufacturing, QC, and IT
- Improves audit readiness — agencies demand justification for exclusions
- Supports risk-based validation planning (ICH Q9)
- Facilitates manageable, phased execution of validation activities
2. Regulatory Expectations
Global regulators emphasize clarity and justification in the scope section of a VMP:
- FDA: Expects documented rationale for scope boundaries (21 CFR 211.100)
- EMA: Requires coverage of all GMP-critical systems, or documented exclusions with justification
- WHO Annex 15: Scope should be “clearly defined
3. How to Structure the Scope Section
- Purpose Statement: High-level summary of what the VMP covers
- Systems and Facilities Included: List all GxP systems
- Processes and Product Types Covered: Include cleaning, manufacturing, packaging, analytical testing
- Systems Excluded and Rationale: Clear justification (e.g., non-GxP, already validated, legacy systems)
- Validation Approach by Category: Full vs partial validation, verification, or qualification only
4. Sample Scope Statement
“This VMP covers the qualification and validation of all new manufacturing equipment, critical utilities (WFI, HVAC), computerized systems (LIMS, BMS), cleaning processes, and analytical methods used in the production of solid oral dosage forms at the XYZ facility. Excluded from this VMP are administrative systems (e.g., email servers), non-GxP laboratory instruments, and equipment used solely for development purposes.”
5. What to Include in Scope
Equipment and Instruments
- Blenders, granulators, tablet presses, coating machines
- Autoclaves, lyophilizers, sterilizers
- HPLCs, UPLCs, dissolution testers (QC)
Utilities
- Water systems (WFI, RO, PW)
- HVAC (temperature, humidity, air flow, HEPA)
- Compressed air and nitrogen
Computerized Systems
- Laboratory Information Management Systems (LIMS)
- Building Management Systems (BMS)
- Manufacturing Execution Systems (MES)
- SCADA systems
Processes
- Cleaning procedures (CIP/SIP/manual)
- Manufacturing and packaging workflows
- In-process checks and controls
- Analytical method validation
Premises
- Production cleanrooms and aseptic areas
- QC laboratories and microbiology labs
- Warehouse for API and finished goods
6. What to Exclude (with Justification)
Exclusions must be listed with clear rationale — not hidden or omitted.
- Office Equipment: Computers, printers, telephones used for admin purposes
- Non-GMP Utilities: Drinking water system, HVAC for non-production offices
- Legacy Validated Equipment: Document prior qualification and reference report ID
- R&D Systems: Clearly state they are used for non-commercial batches
- Non-product-contact Instruments: e.g., balances in stores, environmental monitors in cafeteria
7. System Categorization Framework
Use a decision tree or matrix to categorize equipment and systems based on criticality:
| System | GxP Impact | Category | Validation Required? |
|---|---|---|---|
| Tablet Press | Direct Product Contact | Critical | Yes |
| WFI System | Used in formulation | Critical | Yes |
| Email Server | No GxP use | Non-Critical | No |
| R&D Dissolution Tester | Non-commercial use | Development Only | No |
8. Linking Scope to Validation Strategy
Once included systems are defined, describe how each will be validated:
- Equipment: DQ/IQ/OQ/PQ approach
- Utilities: Qualification + Environmental Monitoring Validation
- CSV: Based on GAMP 5 lifecycle model
- Processes: Stage 1–3 (PPQ and CPV)
- Cleaning: Worst-case product approach with MACO calculations
9. Best Practices for Defining Scope
- Use flow diagrams to visually show facility boundaries
- Map systems against user requirement specifications (URS)
- Maintain an annexed “Validation Inventory List”
- Review scope during any major change (e.g., facility expansion)
- Use version control and justification log for scope updates
10. Common Audit Observations
- Unclear justification for excluded systems
- Missing rationale for validating only partial process steps
- Discrepancy between system list in VMP and equipment logbooks
- VMP includes systems not in actual use or already decommissioned
- No categorization (critical vs non-critical) in scope section
11. VMP Scope and Related SOPs
Scope references in the VMP should be aligned with key SOPs such as:
- SOP for Equipment Qualification
- SOP for Cleaning Validation
- SOP for Computerized System Validation
- SOP for Change Control and Risk Assessment
Conclusion
A well-defined VMP scope is essential for effective validation governance. It must be clear, comprehensive, justified, and aligned with regulatory expectations. By explicitly stating what is included, what is excluded, and why, pharmaceutical companies can streamline validation efforts, reduce audit risks, and enhance cross-functional alignment.
To download customizable VMP templates with scope checklists and system inclusion decision trees, visit PharmaValidation.in or explore SOPs and annexes at PharmaSOP.in.