POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 140

TABLE 7.1 Typical Construction/Qualification Project Phases and Activities
Engineering Construction Commissioning Qualification

• System and component
impact assessment
• Vendor quality audit plan
development
• Design qualification plan
development
• Construction quality plan
development
• Engineering change plan
development
• LOTO (lock out tag out) plan
development
• Equipment inspection plan
development
• Mechanical completion plan
development
• Systems boundaries defined
• Automation requirement and
design
• Schedule development

• System/construction impact
assessment
• Quality vendor audit
• Design qualification
• Construction quality plan
execution
• Engineering change
management
• LOTO procedure execution
• Equipment and automation
FAT
• Mechanical plan execution
• Commissioning plan
development
• Qualification plan
development
• Calibration and maintenance
plan development
• Construction inspections
• Automation development
testing

• Equipment and automation
FAT/SAT
• Turn over package review
• Instrument check
• Functional check
• System shake down
• System performance testing
• Punch list mitigation
• Calibration and maintenance
plan execution
• SOP development
• Training plan development
and execution
• Resource plan development
• Engineering change control

• Installation verification or
qualification
• Operational verification or
qualification
• Process performance
qualification
• cGMP change control
• Resolution of deviations