In this article we explain what QMP is, when it is necessary and why it can make a difference in the success of a GMP project.
What is a Qualification Master Plan (QMP)?
The QMP is a strategic document that defines the qualification plan for equipment, systems, environments and utilities involved in a production process subject to GMP (Good Manufacturing Practice) standards.
It serves to:
- Outline which components should be qualified
- Determine the required qualification level
- Define the responsibilities of the teams involved (QA, engineering, validation, production)
- Establish timing, methods and acceptance criteria
It is the official reference for all stages of IQ/OQ/FP.
QMP vs VMP: What Differences?
Very often QMP and VMP are used interchangeably, but actually cover different areas:
Often the QMP is attached or integrated into the VMP, but in complex projects (new production areas, expansions, cleanrooms) it can be developed independently.
What does a good QMP include?
An effective Qualification Master Plan must contain:
- Detailed list of equipment to qualify
- Classification according to criticality and risk (risk-based approach)
- URS Matrix ? DQ ? IQ ? OQ ? PQ
- Timeistics and milestones
- Roles and responsibilities (e.g. QA approver, validation owner, etc.)
- Protocol models (template IQ/OQ/PQ)
- Strategies for deviation management and change control
- Criteria for final acceptance
When is a QMP?
QMP is required whenever you qualify critical physical elements for GMP compliance, for example:
- New clean rooms or classified environments
- HVAC systems, air treatment plants, RABS
- Critical equipment (autoclaves, LAF benches, incubators, TOC systems)
- Purified water systems or pure steam
- Restructuring with impact on environments or processes
The role of the QMP in the GMP strategy
Have a well-structured QMP:
- Reduces risk of non-compliance during audits and inspections
- Ensure consistency between URS (User Requirements) and actual qualification
- Promotes the efficiency of technical teams and QA
- Documents the traceability of the commissioning and validation process
It is also a useful tool in case of outsourcing: it allows you to transparently define the perimeter and responsibilities between customer and supplier.
Do you want to draw up a GMP-compliant Qualification Master Plan?
QSGroup supports its customers in the drafting, execution and review of Qualification Master Plan for classified plants, tools and environments.
From strategy to documentation, we support your team to ensure compliance, efficiency and traceability.
Contact us to receive an adaptable QMP model or request a dedicated consultation.
