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/distribution/logistics 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
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 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