What is an expert for protein production without a quality assurance expert? Our quality system for the cGMP-compliant manufacture (process development, production and quality control) of biotechnical pharmaceutical actives meets the highest of demands. WACKER’s quality system is based primarily on sections 2 and 19 of the ICH Q7 guideline “GMP Guide for Active Pharmaceutical Ingredients” and the EU Good Manufacturing Practice Guideline.
Thanks to our quality assurance network, we are highly effective in regulating all relevant issues and are intent on continuously improving the system. In addition to creating the required specifications for implementing GMP-compliant work processes in practice and our extensive validation tasks, another of our priorities is meticulous employee training: only a system that has the benefit of active support can ensure the necessary product quality and safety. Our quality system and its GMP compliance is regularly audited by ourselves, our customers and the authorities.