Regulatory library

FDA guidance: Process Validation: General Principles and Practices

FDA's 2011 guidance describes process validation as a lifecycle in three stages: process design, process qualification and continued process verification. Equipment and utility qualification sits inside the second stage.

ValDoc's library holds 1 provision of FDA guidance: Process Validation: General Principles and Practices. It can apply to URSs for biosafety cabinets, centrifuges, cryogenic systems, controlled temperature units, environmental monitoring, incubators, label printers, stability chambers, sterilization equipment, transport systems, thermal sealing and welding systems and vacuum pumps, depending on their intended use. This page is guidance in our words. The regulation's own text governs.

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Equipment it reaches

Baseline requirements that cite it

  • The site shall approve a risk-based qualification strategy and trace applicable URS requirements to design review, installation, operating and performance evidence with deviations resolved before release.

Provisions in ValDoc's library

  1. FDA guidance: Process Validation: General Principles and Practices, Section IV

    Effective JAN2011

    Process Validation: General Principles and Practices

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See your own equipment in ValDoc.

Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.

Thirty minutes. Bring one piece of equipment.