Start with the Validation Master Plan
The VMP or equivalent should define the qualification and validation policy, organizational responsibilities, system boundaries, lifecycle approach, acceptance governance, deviation handling, change control and requalification strategy.
Plans should identify which facilities, utilities, equipment and processes require qualification or validation and explain how quality risk management determines the depth of work.
The qualification lifecycle
User requirements define intended use and critical needs. Design Qualification demonstrates that the proposed design can meet those needs. FAT and SAT may provide reusable evidence when their scope, controls and documentation are adequate.
Installation Qualification verifies the installed state. Operational Qualification challenges operating ranges, alarms and controls. Performance Qualification demonstrates reproducible performance with representative materials, loads, procedures and trained operators.
Protocols, deviations and release
Protocols should define critical systems, test methods, acceptance criteria and responsibilities before execution. Deviations must be recorded, assessed for impact and resolved or formally accepted before phase approval.
Conditional progression between stages must be exceptional, documented and supported by an assessment showing that unresolved matters do not create unacceptable risk to the next phase or product quality.
Maintaining the validated state
Qualification is not finished at the initial summary report. Preventive maintenance, calibration, monitoring, periodic review, change control and deviation trending provide evidence that the validated state remains controlled.
Requalification frequency and scope should be justified by risk, performance history, changes and regulatory commitments rather than applied as an automatic calendar exercise.
A defensible execution path
- 1Define URS and critical risks
- 2Qualify design and installation
- 3Challenge operation and performance
- 4Maintain control through review and change management
Frequently asked questions
What is the difference between qualification and validation?
Qualification generally demonstrates that facilities, utilities and equipment are correctly installed and perform as intended. Validation demonstrates that a process or method consistently produces the expected result.
Are FAT and SAT required by Annex 15?
They should be considered where appropriate. Suitable, documented supplier tests may be leveraged later when their scope and integrity are assessed and the functions are not adversely affected by transport or installation.
Does Annex 15 require fixed requalification intervals?
It requires justified periodic evaluation and requalification where appropriate. The interval and scope should be based on risk, performance, changes and applicable commitments.
Primary references
Use the current official publication and your applicable national requirements when approving a protocol or quality-system decision.
Need support applying this to your facility?
PHARPRO can scope the qualification, review your current documents or execute the work with your site team.
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