Qualification
The qualification of equipment, systems and processes in pharmaceutical plants and facilities is essential to safeguard the quality of pharmaceutical products. This is why VOGELBUSCH BIOPHARMA focuses on seamless qualification right from the start. Our long-standing experience concerning the design, construction and commissioning of facilities enables VOGELBUSCH BIOPHARMA to offer its customers a wealth of know-how for each and every qualification task.
VOGELBUSCH BIOPHARMA will prepare qualification plans tailored exactly to each customer’s needs (masterplan including partial qualification project) and take care of protocol development in accordance with customer guidelines. We also perform GMP-compliant factory acceptance tests (FAT) using our own measuring equipment and establish GMP-compliant, end-to-end project and facility documentation. Based on procedures developed in advance or conforming to the customer’s standardized processes and recording procedures, VOGELBUSCH BIOPHARMA will ensure efficient IQ, OQ and PQ implementation and support in strict conformity with tried-and- tested qualification mechanisms.
IQ = Installation Qualification
OQ = Operational Qualification
PQ = Performance Qualification
Certification
VOGELBUSCH BIOPHARMA GmbH may have the following certificate for this purpose