GMP PROJECT QUALITY SYSTEM

GMP PROJECT QUALITY SYSTEM

Are you about to start a GMP Facility/Equipment Project involving Design, Procurement, Fabrication/Construction, Testing and Qualification of manufacturing equipment, processes and facility?

How does the Client and the Contractor:

  • communicate with each other with respect of GMP and Quality System requirements?
  • establish a BENCHMARK to ensure both parties can quantify the requirements and the deliverables including documentation for Equipment Qualification?

E03-5000 A Simple Quality-System Model for GMP Projects is a FREE DOWNLOAD – provides a Project phase by phase description and a Process Map for your GMP Projects.

What is your experience dealing with Client or Contractor?  What is sufficient information or documentation to meet QA  & Validation requirements?