Design Review
As early as the planning phase of production buildings, premises and equipment, it must be ensured that they are designed and configured to meet requirements. This also applies to the associated infrastructure. In addition to the requirements based on product and process, compliance with GMP regulations must also be met. This is done at an early stage with the help of a GMP design review. But when is early, when is the ideal time? What level of detail needs to be considered to safely meet GMP requirements? Is "good engineering practice" not sufficient here? Demonstrably not! In close coordination with the customer, MedCycle-Consulting reviews the design with a view to the relevant regulations and proposes solutions. Experience and expertise ensure successful, GMP-compliant construction and conversion projects here.
Comprehensive knowledge: industry, technology, regulations
Many years of practical experience in many industries and extensive knowledge of a wide variety of technologies are the basis for being able to carry out design reviews safely and quickly. In conjunction with precise, up-to-date knowledge of the relevant regulations. The range of services includes the GMP design review of technical planning documents
- New construction/conversion of a manufacturing plant or a sub-system
- Room concepts and room plans with
- material and personnel flows
- Room divisions such as incoming and outgoing goods, lock concepts, production rooms, quality control and storage areas
- Pressure stage concept
- Ventilation system
- Media supply
- Equipment
- Design specifications such as URS, FDS, DDS, etc.
A system that reliably meets the GMP requirements
The expert review shows the ability of the entire technical system to meet the quality requirements. Potential weaknesses are already identified in the design phase and possible solutions are presented. Clear, practice-oriented, feasible. A GMP design review, which can be carried out in different project stages, is basically an essential final examination of the respective design and planning phase. It must still be possible to make changes to the design so that all GMP requirements can be met.
GMP design review: Fast support, routine procedure, cost transparency - planning security
Design reviews can be carried out at short notice and usually very quickly. The duration of the review depends on the complexity of the documents to be checked. Customers receive planning security through the routine approach of the GMP experts.