Services

GMP Compliance Consulting
  • System based Facility GMP Audit -> Gap Analysis -> Recommendations -> Implementation with respect to Facility, Utilities, Process Equipment, Lab Instruments, Computer Systems and Quality Management System
  • Audit Preparation, Support to In-House Experts and On-Site Support during the Audit
  • Facility Design Review for GMP Compliance with USFDA, EU, TGA, SFDA, WHO and CDSCO
  • Facility Risk Assessment based upon OEL / OEB Categories (HAZOP)
  • Vendor GMP Audit