GMP Audits (Qualification & Routine)

GMP Audit ensures control of processes parameters are robust enough to prevent even minor variations in process, and ultimately final product quality.

▪ API/Formulation Manufacturer
▪ Excipient/Raw material Manufacturer
▪ Investigational Medicinal Product (IMP) Manufacturer
▪ Contract Packaging Organizations
▪ Contract Manufacturing Organizations
▪ Pre-inspection audits for Sponsor site/CMO
▪ Pre-selection contractor audits on behalf of a sponsor
▪ Routine review audits of existing contractors
▪ Vendor audits- API, excipient and packing component audits

Our GMP experts are well versed with the knowledge of ICH Guidelines, EudraLex volume4, IPEC and/or USP guidance and ISO guidance. We have GMP auditors globally available.