To ensure the quality of pharmaceutical products, the qualification of equipment, systems and processes is an essential component of pharmaceutical plants. This is what we at VOGELBUSCH BIOPHARMA have been greatly emphasising from the very beginning. With many years of experience in the planning, construction and commissioning of plants, VOGELBUSCH BIOPHARMA offerscv its customers comprehensive know-how for every qualification task. Perfectly adapted to customer requirements, VOGELBUSCH BIOPHARMA prepares qualification plans (master plan to partial qualification project), adopts the protocol development including customer guidelines, implements GMP-compliant factory acceptance tests (FAT) with its own measuring equipment and establishes seamless documentation systems for consistent, GMP-compliant project and plant documentation. Based on previously developed procedures and logging already standardised by the customer, VOGELBUSCH BIOPHARMA provides efficient IQ, OQ, PQ implementation & support with strict adherence to common qualification mechanisms.
IQ = Installation Qualification
OQ = Operational Qualification
PQ = Performance Qualification