Pharmaceutical Water System Validation/DQ/IQ/OQ/PQ Documents

Pharmaceutical water system validation is a multi-stage process to ensure a water system consistently produces water that meets required quality standards for pharmaceutical use. It involves four main phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This comprehensive process is essential for regulatory compliance, product quality, and patient safety.

1. Design Qualification (DQ)

• What it is: Verifying that the system's design, based on specifications, is suitable for its intended purpose.
• Key activities: Reviewing system design documents, water sources, purification technologies, storage, and distribution systems to ensure they meet standards.

2. Installation Qualification (IQ)

• What it is: Confirming the system has been installed correctly according to the approved design specifications.
• Key activities: Verifying equipment placement, checking calibration of instruments, and ensuring all safety procedures were followed during installation.

3. Operational Qualification (OQ)

• What it is: Testing the system's performance under normal operating conditions to ensure it functions as intended.
• Key activities: Measuring and documenting parameters like flow rates, pressure differentials, temperature controls, and alarm systems. Water quality parameters are also tested to ensure they stay within defined limits.

4. Performance Qualification (PQ)

• What it is: Evaluating the system's ability to consistently produce the desired quality of water over an extended period.
• Key activities: Testing the system under various conditions, including "worst-case" scenarios, to demonstrate reliability and consistent performance over time. This phase is often conducted over several weeks and can involve using the water in actual manufacturing processes.

Ongoing validation and control

• Periodic revalidation: A revalidation is performed periodically (e.g., every 1-3 years) to ensure the system continues to meet specifications.
• Revalidation after changes: Revalidation is required after any significant changes are made to the system, such as adding components or repairing major equipment.
• Change control: A formal process is needed to manage any modifications to the system.

Routine monitoring and maintenance: Regular monitoring of water quality parameters and a systematic maintenance program are crucial for keeping the system in a validated state