Pharmaceutical Qualification and Validation Support
NINGRUI provides qualification and validation consulting and coordination for pharmaceutical project systems. The scope can address cleanrooms, HVAC, clean piping, and computerized systems, with activities defined around the intended use and project stage.
Establish the Evidence the Project Needs
The work starts with user requirements and a review of the system's functions and quality risks. Agreed support can include qualification planning, protocol and document coordination, testing arrangements, and review of results and open items.
| Stage | Purpose of the Agreed Work |
|---|---|
| Design qualification (DQ) | Review the proposed design against the requirements |
| Installation qualification (IQ) | Verify the installed system against approved specifications |
| Operational qualification (OQ) | Assess operation across the defined conditions and limits |
| Performance qualification (PQ) | Assess performance under the intended process conditions |
The applicable stages, tests, and documents depend on the system and risk assessment. Supplier documents and acceptance testing may contribute evidence where their relevance is established.
Plan Reviews and Responsibilities Before Testing
- Define the system boundary, intended use, existing evidence, and required project activities.
- Agree the plan, acceptance criteria, document responsibilities, and review roles with your technical and quality teams.
- Coordinate the agreed checks and tests, recording results and deviations for review.
- Assemble the evidence and open-item status for the responsible project and quality personnel to assess.
Testing and document production need defined approval arrangements. The site retains responsibility for its quality decisions and authorization to use the system.
Information for an Initial Scope
Provide the user requirements specification (URS), system list, project stage, and available design or supplier documents. Include applicable requirements, existing qualification status, test records, open issues, and proposed review responsibilities.
For changes to an existing installation, identify the change and the systems or functions it may affect.