Medical Devices

GxP Material and Service Supplier Audits

  • As directed by our clients, we execute internal and external GxP quality systems audits according to distinct local regulatory requirements including US, Canadian and/or EU requirements – or any other unique client requirements
  • GMP related audits include: drug product and API manufacturers; component, raw material and excipient suppliers; testing laboratories; labeling/packaging suppliers
  • GCP related audits include: CROs for study management, data management, safety management and Pharmacovigilance; clinical and bioanalytical labs; investigator sites
  • GLP related audits include: bioanalytical labs; full GLP non-clinical testing sites; GLP test article manufacturing sites
  • GDP related audits include: wholesalers; distributors; third-party logistics (3PL) providers
  • GVP related audits include: pharmacovigilance related service providers, including medical information service providers and call centers
  • Regulatory related: submission preparation service providers
  • We also conduct global mock inspections in preparation for GxP, CLIA, device, ISO or other related regulatory, certification, or accreditation inspections
  • Due to a variety of cost-optimization options and techniques, RMC expert GxP quality systems audits can be more cost-effective than audits conducted by internal personnel (see example case study for Cost Effective GMP API and Supply Chain Audits)
  • All RMC audits (inspections) are conducted on behalf of clients according to a written agreement with the client and, if requested, RMC's approved Quality Manual and written procedures which are modeled to meet the requirements of ISO 17020 First Edition 1998-11-15 General criteria for the operation of various types of bodies performing inspection