Qualification DQ, IQ, OQ, PQ
Putting performance to the test. Showing that everything works as it should, proving it, documenting it - that's what qualification of technical systems means. The aim is to reliably meet the necessary quality standards and thus official requirements, while acting in a measured and resource-conserving manner.
Proof is not testing – DQ, IQ, OQ, PQ
Proving means showing, not testing.
- The aim is to show that a technical object - a device, an apparatus or a system - has been constructed/designed in accordance with GMP. | DQ Design Qualification
- Is set up, connected and installed as planned | IQ Installation Qualification
- Functions as intended in all operational areas | OQ Operational Qualification
- And performs as intended in its entirety | PQ Performance Qualification
Showing has to do with proving. Because when proving, you know the result you have to achieve or meet the acceptance criteria within the scope of the qualification. Medcycle with years of experience in qualification knows the subtle but essential difference and therefore knows exactly what authorities want to see in the end.
Systematics and formalism - guarantors for comprehensive quality
Comprehensive and expert evidence. A systematic approach is essential: structured, planned, coordinated. MedCycle-Consulting knows all forms of qualification planning, the corresponding SOP's and protocol and report templates. Developed, optimized templates are used, if necessary also customer templates. Key documents are:
- Master plan
- Specifications
- Impact assessment
- Risk analysis
- Traceability matrix
- Qualification plans and reports
- Deviation reports
- Final reports
It is important here to comply with previously defined processes and to create and edit the necessary documents in the correct order. A certain formalism leads to security here, both for product quality and for audits and inspections.
When time becomes a success factor – use synergies
Planning, construction or conversion of pharmaceutical plants - here, qualification is an add-on. A service to be provided in addition to the engineering tests and acceptances, which has an impact on costs and time. Optimization results from integrated qualification. Acceptance tests carried out by manufacturers of technical equipment at their plants as FAT Factory Acceptance Tests and later at the installation site as SAT Site Acceptance Tests can be usefully integrated into the qualification process. Lean qualification despite complex processes.
Inventory and requalification – risk-based and measured
You don't always have the chance to start directly with a new system. If the system is already in place, structural conditions, limited testability and often a lack of documentation and certificates determine the picture. In order to still meet the quality and thus official requirements in an economical and moderate manner, a risk-based approach is required. Together with a sense of proportion and experience. The same applies to the topic of re-qualification. Medcycle-Consulting contributes exactly this knowledge: well-founded technical expertise and extensive practical experience with regard to existing requirements. In this way, existing and re-qualifications can be reduced to a reasonable level.