Putting performance on the test stand. Showing that everything is as it should be and is working as it should, proving, documenting - this means qualification of technical equipment. What applies in private life – for instance driving a new vehicle to the limit first off – is even more important in GMP-regulated environments. Only the standards for a systematic approach and documentation are higher here. The goal is to ensure that quality standards and therefore legal requirements are reliablymet while operating with restraint and conserving resources.
Proving is Not Testing – DQ, IQ, OQ, PQ
Proving means showing, not testing. DQ Design Qualification means showing that a piece of technology – a device, apparatus, machine or system – has a GMP-compliant design. IQ Installation Qualification means showing it is set up, connected and installed as planned. OQ Operational Qualification means showing it works as intended in all respects. PQ Performance Qualification means showing it delivers the overall desired performance. Here showing is related to proving. With proving one knows the results and has to reach or meet the acceptance criteria in the course of qualification. With years of qualification experience, gempex is aware of the subtle but essential distinction and therefore knows exactly what the authorities want to see in the end.
Systematics and Formalism – Guarantors for Comprehensive Quality
Proving completely and with expert knowledge. A systematic approach is essential here: structured, planned, coordinated. gempex is familiar with all forms of qualification planning as well as the corresponding records and report templates. Optimised templates developed in house – or by request also customer templates – are used. Key documents include:
- master plan
- user requirement specification
- impact assessment
- risik analysis
- traceability matrix
- qualification plans and reports
- deviation reports
- final reports
- and much more
Here it is important to follow processes established in advance, and to prepare and edit the required documents in the right order. A certain formalism leads to reliability here, both for product quality and during audits and inspections.
When Time Becomes a Success Factor – Realising Synergies
Planning, construction or reconstruction of pharmaceutical plants – here qualification is an add-on. A task to be done in addition to engineering tests and acceptance procedures, taking up time and generating costs. Optimisation is possible through integrated qualification. Integrating acceptance procedures conducted by manufacturers of technical equipment in the factory as a FAT Factory Acceptance Test and later at the installation location as a SAT Site Acceptance Test into the qualification is expedient. Pre-commissioning and commissioning activities can be integrated as well. Streamlined qualification notwithstanding complex processes.
gempex through cooperation has developed a detailed process model – 3C Management: Construction, Commissioning, Compliance. It helps save time, reduce costs and realise synergies to a large extent.
Initial and Requalification – Risk-based and Restrained
Starting directly with a new facility is not always possible. When a system has already been installed, the situation is determined by structural circumstances, limited auditability and often missing documentation and certificates. A risk-based approach is needed here in order to meet quality standards and therefore legal requirements economically and with restraint. Experience and a sense of proportion are essential as well. This applies equally to requalification. gempex contributes precisely this knowledge: established technical expertise and comprehensive practical experience regarding existing requirements. As a result, initial and requalifications can be reduced to a reasonable extent.
- decades of experience with qualification
- optimised process models and corresponding templates
- time savings and cost reduction through an integrated and risk-based approach
- approaches for existing facilities
- cost-optimised requalification models
- inspection readiness