Starting in the design phase for production buildings, facilities and equipment, it is essential to ensure that their layout and design meet the requirements. This also applies to the associated infrastruture. In addition to requirements imposed by the product and process, compliance with GMP regulations is essential as well. This is accomplished in an early phase with the help of a design review. But when is early, what is the ideal time? What level of detail needs to be examined to meet GMP requirements with certainty? Are “Good Engineering Practices” sufficient here? Demonstrably not! In close coordination with the customer, gempex reviews the design with an eye on the relevant regulations, offering alternatives and proposing solutions in case of findings. Experience and technical expertise ensure successful, GMP-compliant construction, upgrade and reconstruction projects.
Comprehensive Knowlege: Industry, Technology, Rules and Standards
Many years of practical experience in numerous industries and far-reaching knowledge of various technologies form the basis for conducting design reviews quickly and reliably. Together with the latest precise knowlege of the respective relevant rules and standards. gempex consultants know exactly what needs to be examined in what depth and where inspection readiness is at risk. The scope of services encompasses the review of technical planning documents for:
- new construction/upgrade/ reconstruction of a manufacturing operation or part of a facility
- room concepts and layout plans with
- material and personnel flows
- room layouts such as goods receiving and shipping, lock concepts, production rooms, quality control and storage areas
- room pressure concepts
- HVAC systemss
- design specifications such as URS, FDS, DDS and many more
A System that Reliably Meets the GMP Requirements
The expert review verifies the ability of the overall technical system to meet the applicable quality requirements. Potential weak points are identified in the design stage and possible solutions are described. Clear, practical, realisable. A design review can be performed at various stages of a project. Fundamentally it serves as an essential final check of the respective design and planning phase. Design changes must still be possible so that all GMP requirements can be met.
Rapid Support, a Proven Approach, Cost Transparency
Design reviews can be performed at short notice and usually very quickly. The duration of the review depends on the complexity of the documents being checked. Customers obtain planning reliability thanks to the proven approach of the GMP expert and a transparent fixed price offer.
- reliably meeting the GMP requirements by the end of the design phase
- no unpleasant surprises in the subsequent phases
- GMP experts with many years of experience across industries
- reconciliation of planning with current technical and regulatory knowledge
- neutral perspective of external experts