Q06-3000 FACILITY & EQUIPMENT REQUIREMENTS (QMS)

Resource requirements and management are critical to support your quality management system and produce quality products:
(1) ensuring that the organization infrastructure (buildings, workplace, facilities, equipment and machinery, associated utilities, etc) is adequate;
(2) production equipment is “fit for intended purpose”
(3) the Work environment is capable to support the quality journey

Some of the topics covered in this sub-category includes:

  • Q06-3000  Facility-Equipment – General Requirements:
    • Facility Design Guidelines
    • System Impact Assessment
    • Component Criticality Analysis
    • Equipment & Drawing Control
    • Facility & Cleanrooms
  • Q06-3100  Facility-Equipment – Quality System
  • Q06-3200  Facility-Equipment – Design Requirements
  • Q06-3300  Facility-Equipment – Project Procurement
  • Q06-3400  Facility-Equipment – Construction
  • Q06-3500  Facility-Equipment – Testing & Commissioning
  • Q06-3600  Facility-Equipment – Equipment Qualification
    • Equipment Pre-Qualification Process & Documentation
  • Q06-3700  Facility-Equipment – Operations & Maintenance
  • Q06-3800  Facility-Equipment – Laboratory

NOTE:

This sub-category Facility & Equipment Requirements do share common templates as in E03-5000 Project Quality System (GEP):

To Open-Download-Print the PDF flowchart –>  E03-50-00_Project_Quality_Sys_Flowchart

GMP Project Roadmap, Steps & Processes for a Simple GMP Project

E03-50-00_Project_Quality_Sys_Flowchart