In simple terms, qualification ensures that equipment, systems, and facilities are installed and operate as intended. It’s all about proving that everything is fit for purpose before you start using it for production.
In the pharmaceutical industry, URS, IQ, OQ, and PQ are critical components of the validation process for ensuring that equipment, systems, and processes meet specified standards and requirements. Here’s a breakdown of each:
URS (User Requirement Specification)
Definition: A document that outlines what the user (end-user or stakeholder) expects from a system, equipment, or process.
Purpose: To specify the functional and operational requirements of the equipment or system, including what it should do, performance criteria, regulatory requirements, and any specific needs related to the product or process.
IQ (Installation Qualification)
Definition: A process that verifies and documents that equipment or systems are installed correctly according to manufacturer specifications and industry standards.
-Installation Qualification (IQ): Ensures the equipment is installed correctly.
Purpose: To ensure that the equipment has been properly installed in its operational environment.
OQ (Operational Qualification)
Definition: A documented process that confirms that the installed equipment or system operates according to its intended functionality and performance specifications.
-Operational Qualification (OQ): Verifies that the equipment works according to the specifications.
Purpose: To ensure that the equipment or system functions as expected under normal operating conditions.
PQ (Performance Qualification)
Definition: A validation process that demonstrates that the equipment, system, or process performs consistently and effectively in real-world operating conditions.
-Performance Qualification (PQ): Confirms that the equipment consistently performs as expected under real-world conditions.
Purpose
To ensure that the equipment or process consistently produces the desired outcomes within specified limits when used for its intended purpose.
- Functional Requirements (FR): Specify how the system should function to meet UR.
- Validation Protocol: Documented plan for validation activities.
- Verification Protocol: Documented plan for verification activities.
Validation Flow:
- URS is created first, outlining user needs.
- IQ ensures the system is installed correctly.
- OQ ensures the system operates as intended.
- PQ ensures the system performs under real conditions.
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