The checklist are GMP/GEP design criteria that needs to be considered during the development, design, construction, testing, qualification and maintenance of process, utilities & building in a facility. The list covers all engineering disciplines.


Purpose of the Checklist:

The checklist consists of design criteria for a facility component that needs to be considered during the life-cycle phases of development, design, construction, testing, qualification and maintenance. This is to ensure the components in the facility are:

  • “fit for intended purpose”,
  • compliant to regulatory/statutory requirements,
  • easy and safe to operate and maintain.

 The checklist:

  • consists of topics relevant to components in a facility eg process, utility, testing, security equipment; building components and fabrics; electrics and controls
  • covers all project disciplines – Architectural, Ventilation/HVAC, Process Equipment, Process/Utilities, Electrical, Process Control and Automation
  • includes design criteria which are typical industry standard
  • the checklist ensures that you have covered all expects in the design, construction, testing and maintenance of components in a facility
  • a missed item or design feature can lead to non-compliance; very expensive and cumbersome retrofit; plus project delays
  • some items are extracted from statutory and regulatory requirements eg FDA CFR 211.42 Building/Facility

The entire checklist in our library includes:

No. of items in each separate Checklist Number of Items in Checklist
E20-52  Architectural 120
E20-53  HVAC 70
E20-34  Process Equipment 155
E20-55  Process & Utilities 150
E20-56  Electrical 125
E20-57 Process Control/Automation 285

The “Sample Checklist” consists of only 60 out of the 900 items. It is available as a “Free Download” to allow you to sample some of the contents of the full versions.

The full versions are supplied in MS Excel for ease of entering data and sorting the items.

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