Qualification
The qualification of equipment, systems, and processes is a key pharmaceutical plant component in terms of pharmaceutical product quality assurance. Vogelbusch Biopharma focuses a great deal of attention on this from the very beginning. With its years of experience in plant design, construction, and startup, Vogelbusch Biopharma offers its customers a wealth of know-how for all qualification tasks. Precisely tailored to client needs, Vogelbusch Biopharma prepares qualification plans (from master plans to partial qualification projects), takes charge of creating protocols according to client guidelines, performs GMP compliant factory acceptance tests (FATs) with its own measuring equipment, and establishes complete documentation systems for continuous, GMP compliant project and plant documentations. On the basis of previously developed or the client’s own standardized operations and logging procedures, Vogelbusch Biopharma provides efficient IQ, OQ, PQ implementation and support in strict compliance with standard qualification mechanisms.
