Equipment Installation Qualification – What Should Be In Your Protocol?

According to cGMP an installation qualification is documented verification that all aspects of a system, facility, utility or equipment that can affect product quality are installed according to specifications and design criteria.

When developing an IQ for your equipment qualification activities there are a number of aspects that need to be considered through the qualification process including:

Equipment Verification

  • Equipment Make
  • Equipment Model
  • Equipment Serial Number

Drawing List & Documentation

  • Update and As-Built
  • P&ID’s
  • Wiring/Logic/Loop Diagrams, Plan Viewr/li>

Note: Can be completed during SAT.

Equipment Install Verification

  • Ensure environment is suitable – Fit For Use
  • Accessible for cleaning/maintenance – Fit For Use
  • Appears clearly labelled (ID, Controls, Safety)

Materials of Construction

  • Includes lubricants (food grade – USDA H1) – Fit For Use
  • All product contact parts (i.e Pump, Filler, Mix Tank) – Fir For Use
  • Attach material certs (preferred) or manufacturer material certification

Utilities Verification

  • All critical utilities required for proper operation of equipment (i.e electrical, water, compressed air, etc) – Fit For Use

Computerised Controls HW/SW

  • For PLC or complex controls systems
  • PLC software (i.e title, version)
  • Hardware – make/model (i.e PLC, OIT, I/O Boards, Power Supplies)

Calibration

  • Critical process devices & test equipment
  • Calibration for all process devices (Temp, Pressure, etc)
  • Any devices used in execution or measuring data (tachometer, caliper, etc)

Preventive Maintenance

  • Document all PM’s
  • Must be a scheduled frequency

Spare Parts

  • Critical spares should be identified
  • List of spare parts should be available in the maintenance shop and stocked – Fit For Use
  • Product contact materials

Equipment Procedures

  • Equipment operation SOP’s – Fit For Use
  • Equipment use logs
  • Cleaning SOP’s – Fit For Use

I/O PLC Connectivity

  • All PLC I/O’s
  • Can be performed by vendor or during SAT
  • Can be printed with “Performed by” sign-off/date y vendor
  • Empty addresses can be N/A’d
  • Simulated or real-time testing
  • Simulate signal with software (i.e force signal in PLC/RS Logix)
  • Manipulate field device (i.e obstruct or “make” photo-eye)
  • Simulate signal with equipment/instrument (i.e strobe generator)
  • Manipulate using OIT

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP