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?
  • prepare all your documentations to ensure your construction is fit for intended purpose
  • have your documentations ready for QA Department or Regulatory Audits

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?

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