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?
- 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?