E10-0300 Critical Utilities - Testing Standards

This sub-category consists of typical Testing & Commissioning procedures and acceptance criteria for GMP Facility & Equipment.

Depending on the project, it may begin with an Inspection & Test Plan for both the Construction provider and User to agree on the processes.

Equipment Qualification is one of the first requirements to regulatory compliance to ensure equipment is fit for intended purpose. This package includes a Summary Report template, a Variance Report template and a process map (from design to qualification).