This article looks at terms used within the biotechnology and pharmaceutical industry relating to engineering and qualification of systems.
The purpose is to provide a consistent approach to terminology in line with current regulations (EMEA, FDA, etc) and regulatory guidance (e.g. GAMP5, ASTMS).
Terms
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Validation
Establishing 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 – (FDA).
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Verification
A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating
correctly. This is an umbrella term that encompasses all types of approaches to assuring systems are fit for use such as qualification, commissioning and qualification, verification, system validation, or other ASTM.
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Design Review
A process or meeting during which a system, hardware, or software design is presented to project personnel, managers, users, customers, or other interested parties for comment or approval. Types include critical design review, preliminary design review, system design review IEEE
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Design Qualification
The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose MHRA.
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Installation Qualification
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations MHRA.
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Operational Qualification
The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges MHRA.
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Performance Qualification
The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approve process method and product specification MHRA.