STANDARD OPERATING PROCEDURE ON VALIDATION AND QUALIFICATION PROCEDURE FOR FACILITY, UTILITY, EQUIPMENT AND PROCESS

Description

The Standard Operating Procedure (SOP) on “Validation and Qualification Procedure for Facility, Utility, Equipment, and Process” outlines the systematic approach for validating and qualifying critical aspects of a manufacturing or production environment. The SOP ensures that all facilities, utilities, equipment, and processes are consistently performing to meet predefined specifications and regulatory requirements, ensuring product quality, safety, and compliance with industry standards.

This procedure encompasses the validation lifecycle, including planning, design, installation, operational, and performance qualification (IQ, OQ, PQ) stages. It covers the validation of facilities and utilities, ensuring that these systems are properly designed, maintained, and function as intended. Equipment qualification ensures that machinery and tools are suitable for their intended use, operate within specified limits, and deliver consistent performance. Process validation verifies that manufacturing processes are robust, reproducible, and capable of producing products that meet quality specifications.

The SOP also provides detailed guidelines for documentation and record-keeping to demonstrate compliance with regulatory agencies such as FDA, EMA, or other relevant bodies. It emphasizes the importance of risk assessment, change control, and continuous monitoring to maintain the validated state. Following this SOP ensures the facility, utilities, equipment, and processes are consistently qualified, compliant, and capable of supporting high-quality production standards.