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Full Description

This Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).

The Commissioning and Qualification Baseline Guide focuses on the engineering approaches and practices involved in providing cost-effective manufacturing facilities in a timely manner that meet their intended purposes. Specifically, the Guide addresses the process of designing, constructing, commissioning and qualifying the facilities, utilities, and equipment regulated by the FDA or other health authorities. This Guide is not intended to address any aspect of process/product validation.

The Guide is primarily intended for facilities, equipment, and utilities meeting regulatory requirements to supply the US market and is aligned with US standards and references. It also may be helpful to manufacturers needing to meet European requirements.

The key concepts defined and used as a basis for this Guide include:

- direct impact systems
- indirect impact systems
- system impact assessment
- good engineering practice (GEP)
- commissioning
- qualification practices
- enhanced design review
- installation qualification
- operational qualification
- performance qualification
- consistent terminology
- documentation requirements