GMP and ISO compliance audits
Valicare conducts your GMP audit for your system evaluation - from the internal departments to the customer to the supplier.
Based on applicable regulations, standards, and guidelines (AMWHV, EU-GMP Part I/II, ICH Q7, ICH Q10, PIC/S, USP-NF ˂1078˃, EN ISO 9001, EN ISO 13485), Valicare reviews the GMP and/or ISO compliance of your systems (based on EN ISO 19011). We analyze the quality and GMP compliance of your products, processes, and documentation system.
We work in the pharmaceutical, medical device, and biotechnology industries and especially with manufacturers of advanced therapy medicinal products (ATMP). Our expert audit team covers the entire range of the respective manufacturing processes. We plan and implement your and your customer's approach or perform the service according to our own established and GMP-compliant procedure.