planning

3. When Should the VMP Be Updated?

The VMP should not be a static document. Instead, it must evolve with project milestones, deviations, and changes.

Trigger Event	VMP Update Required?	Example
New equipment installation	Yes	New coating pan in granulation line
Change control raised	Yes	Change in cleaning procedure for capsule filler
Facility expansion project	Yes	Adding new QC lab
Periodic review cycle	Yes	Annual VMP review triggered by QA
Decommissioning of systems	Yes	Retiring legacy HPLC system

4. Linkage Points: VMP and Change Control

To connect your VMP with change control effectively:

• Include a section in the VMP titled: “Integration with Change Control and Deviation Management”
• Reference the Change Control SOP in the VMP (e.g., SOP/QA/027)
• Use cross-referencing: Each system listed in the VMP should note any pending or approved change controls
• Maintain a “Validation Impact Assessment” form as part of change control

5. Lifecycle Alignment: VMP Across Project Phases

Phase 1 – Concept and Feasibility

• Define what systems/processes will require validation
• Start VMP draft early, in alignment with URS development

Phase 2 – Design and Procurement

• VMP should include list of all critical systems and risk classification
• Document expected DQ/IQ/OQ/PQ stages for each item

Phase 3 – Construction and Commissioning

• VMP is revised to include actual equipment/utility tag numbers
• Link commissioning reports as annexures

Phase 4 – Validation and Handover

• All change control numbers affecting validation are listed in VMP
• Final validation reports and deviation summaries are referenced

6. Creating a Dynamic VMP Update System

To ensure the VMP evolves in real-time, implement the following practices:

• Version control: Maintain controlled VMP versions with audit trails
• VMP update SOP: Define frequency and triggers (e.g., change control, CAPA)
• Validation Inventory Tracker: Excel/database to track all validated systems and their current status
• Change Control Template: Include a mandatory field: “Is VMP update required?”

7. Sample Validation-Change Control Matrix

Change Control No.	System	Impact	Validation Required	VMP Update
CC-2024-005	Tablet Press	Software Upgrade	Yes – Requalification	Yes
CC-2024-006	Purified Water Loop	New Return Line Added	Yes – PQ Only	Yes
CC-2024-007	Weighing Balance	Minor Location Change	No	No

8. Best Practices

• Involve QA in early project phases to ensure VMP readiness
• Train engineering and project teams on VMP triggers
• Use project kick-off meetings to identify validation impact
• Tag changes in CAPA/Deviation logs with validation codes
• Always close the validation loop before closing change control

9. Real-World Example

In a recent facility expansion project, a VMP was updated six times to incorporate:

• Installation of new HVAC zones for sterile manufacturing
• Change in API drying process requiring new tray dryers
• Addition of SCADA for process control and electronic batch records

Each change control listed corresponding validation protocol IDs, risk assessments, and an annexure in the updated VMP.

10. Integration with Related Systems

Link your VMP system with other validation-related platforms:

• SOP Management Systems
• Change Control Register
• CSV Protocol Repositories
• Master Validation Plan Archives

Conclusion

The modern VMP is no longer a static document — it is a living interface between validation planning, change control, and project lifecycle governance. By embedding validation thinking into change management and project workflows, pharma organizations can maintain a compliant, efficient, and auditable validation program. Ultimately, this improves product quality, reduces surprises during inspections, and ensures a state of control throughout the product lifecycle.

For downloadable VMP templates with change control integration, visit PharmaValidation.in. Explore related SOPs and audit-traceable tools at PharmaSOP.in.

References

• FDA 21 CFR 211
• ICH Q9, Q10
• EMA GMP Annex 15
• WHO Technical Report Series Annex 15