Qualification & Validation

User Requirement Specification (URS)

A User Requirements Specification (URS) defines the critical requirements for facilities, services, equipment, and systems in a regulated environment. It serves as a blueprint for the entire project or a specific piece of equipment.

The URS is typically prepared in the early stages of procurement, after business case development and validation planning but before purchase. It outlines the expectations and specifications that the equipment or system must meet to ensure compliance with Good Manufacturing Practices (GMP).

Design Qualification (DQ)

Verification that the chosen design meets the URS. Prepared with vendor collaboration before installation. The main objectives of design qualification are to ensure that the design incorporates all process and product requirements, addresses quality and regulatory requirements, and verifies the critical aspects necessary for implementing these requirements and risk controls.

Installation Qualification (IQ)

Confirms equipment installation aligns with approved design and manufacturer requirements. Installation Qualification (IQ) should be performed on equipment, facilities, utilities, or systems.

IQ should include, but is not limited to, the following: verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications; verification of the correct installation against pre-defined criteria; collection and collation of supplier operating and working instructions and maintenance requirements; calibration of instrumentation; and verification of the materials of construction.

Operational Qualification (OQ)

Tests the system to ensure all functionalities operate correctly within defined parameters and environmental conditions. Operational Qualification (OQ) normally follows IQ, but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).

OQ should include, but is not limited to, the following: tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed; and tests to confirm upper and lower operating limits, and/or “worst case” conditions.

The completion of a successful OQ should allow the finalisation of standard operating and cleaning procedures, operator training and preventative maintenance requirements.

Performance Qualification (PQ)

Final stage where system performance is verified under real-world working conditions to ensure consistency and reliability. Performance Qualification (PQ) should normally follow the successful completion of IQ and OQ. However, it may in some cases be appropriate to perform it in conjunction with OQ or Process Validation.

PQ should include, but is not limited to, the following: tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst case batch sizes. The frequency of sampling used to confirm process control should be justified; and tests should cover the operating range of the intended process, unless documented evidence from the development phases confirming the operational ranges is available.