Baxter has strong relationships with the FDA and other global regulatory agencies including the EMEA and JMHW, and has had consistent success shepherding products through the development and approval processes.   Our QA/QC and regulatory teams are fully staffed to generate and integrate cGMP documentation for regulatory submissions. Baxter’s quality systems ensure cGMP compliance for biopharmaceutical manufacturing. Our fully deployed quality systems consist of:   • GMP documentation • Validated critical systems • Deviation tracking • Non-conformance • Change control • Validation • Manufacturing processes • Utility and system maintenance • Cleaning and sanitization • Metrology • Monitoring systems batch review • Material testing • Product release • Design control • Internal assessment • Materials and vendor qualification • Customer feedback management      Privacy Policy