Focusing on the pharma industry the name of the trade is validation. According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” Validation is a requirement for Good Manufacturing Practices (GMPs) and other regulatory requirements.
Guidelines for validation are set by the FDA (and EOF), but the specifications of validation are determined by the pharmaceutical/biotech company.
The phases of Validation are:
- Design qualification (DQ): Documented verification of the design of equipment and manufacturing facilities.
- Installation qualification (IQ): Documented verification of the system design and adherence to manufacturer’s recommendations.
- Operational qualification (OQ): Documented verification of equipment or system performance in the target operating range.
- Process Performance Qualification (PQ): Documented verification that equipment system operates as expected under routine production conditions and that the operation is reproducible, reliable and in a state of control.
VPC has been involved in many clean rooms and pharma projects providing all or part of the above services. Except pharma, our experience includes animal houses, laboratories, Intensive care units, operating theaters, and hospitals.