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Equipment — Overview

Every piece of equipment that touches your product or measures a critical parameter must be fit for purpose, properly maintained, and calibrated. This section covers how to qualify, clean, and control your machinery and instruments.

What this section covers

  • Equipment qualification — Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Equipment register — master list of all GMP-relevant equipment
  • Calibration programme — instruments that measure weight, temperature, pH, etc.
  • Cleaning and sanitisation of equipment — validated cleaning procedures
  • Preventive maintenance programme — scheduled servicing
  • Equipment logbooks — recording use, cleaning, and maintenance
  • Handling breakdowns and non-conforming equipment — tagging, quarantine
  • Dedicated versus shared equipment — managing cross-contamination risk