Cleanroom Qualification, Pharmaceutical Manufacturing License and Tissue Establishment Licence
New cleanrooms GMP class A-D were built which needed full qualification (URS-DQ-IQ-OQ) for ERC in Schaijk. ERC develops and manufactures tumor-vaccins. The project included the establishment of the user requirements and documentation of the DQ, IQ and OQ. The microbial- and non-microbial environmental testing (particles, pressure, etc.) are performed by two companies in a partnership with Rhumbline Consultancy.
In three months’ time, the Quality System, Site Master File, QMS procedures and processes are established and documented in full compliance with EU-GMP and Directive 2004/23/EC, 2006/17/EC and 2006/86/EC.
The quality system and documentation are inspected by the IGZ. ERC-Netherlands obtained the Pharmaceutical Manufacturing Licence and Tumor Tissue Bank Netherlands and obtained the Tissue Establishment Licence from IGZ/Farmatec.