Global regulatory agencies require manufacturers to conduct audits of suppliers and contract manufacturers to verify the suitability of their quality management systems (QMS).

As certified GMP Auditors, we can help ease the burden on the quality team especially for those companies with numerous API suppliers by providing additional resources to manage the supplier audit programme.

We offer a wide range of internal and external Good Manufacturing Practice (GMP) compliance audit services, including:

  • Client site pre-inspection audits
  • On site support during regulatory inspections (German and/or English)
  • Client site open-book audits to confirm GMP standards
  • Pre-selection contractor audits on behalf of a client
  • Routine review audits of existing contractors
  • Supplier audits plus API, excipient and packing component audits
  • For cause CAPA audits

Our auditors are highly experienced industry experts who understand processes and the operator perspective. Our auditors go through an intensive auditor training program leading to independent certification as pharmaceutical auditors.