Process Equipment Qualification is the verification that the equipment is properly designed, installed and operates within defined specifications as devised and specified in the URS.
About the GMP requirements to equipment qualification!
The pharmaceutical industry requires GMP compliance with regulatory authorities such as the U.S. Food & Drug Administration (FDA) or European Medicines Agency (EMA) to receive the manufacturing authorization. Equipment qualification is part of the GMP requirements and follows an elaborate qualification process.
General Principles & Practices
What is process equipment?
- The manufacturing of biotechnological-derived medicinal products involves several process steps from upstream to downstream operations. Various process equipment is used for the bioprocessing of biopharmaceuticals and immunotherapies.
- The process equipment varies from standard to complex equipment and devices used for production. Equipment used in a GMP-related environment should be suitable and should not present any hazard to the product. The location and installation of the equipment should be adequate to minimize risk and contamination.
Why is equipment qualifcation necessary?
- The objective of process equipment qualification is to verify the fitness for purpose for its intended use and to ensure that process equipment meet their specifications as devised in the URS.
Implementation of equipment qualification
- The qualification process outlined in the qualification plan include URS, risk assessment, and lifecycle management.
- Process equipment should be qualified according to the Qualification Phases (DQ, IQ, OQ, PQ), calibrated, inspected and maintained at defined intervals to ensure adequate performance. Associated computerized systems (CS) should be validated to verify data integrity and data security.
When is qualification needed?
- Regulatory compliance with Good Manufacturing Practice (GMP)
- New equipment installation
- Equipment modification
- Maintenance or repair
- Change in the manufacturing process
Key Activities
- Coordination, monitoring and participation in maintenance, calibration and qualification activities in all GMP areas (quality control, manufacturing, IT-infrastructure).
- Contributing to calibrated, maintained and qualified process equipment in compliance with GMP, FDA, EMA, and ISO standards.
- Managing the GMP lifecycle: planning, execution, review, approval, and documentation.
- Coordination, participation and contribution to commissioning and qualification operations with QC, QA, Manufacturing, and IT (DQ, IQ, OQ, PQ).