that critical parameters are monitored and recorded during testing.
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the mixing tank with agitator are carried out in compliance with this SOP and meet all regulatory requirements. QA is also responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the mixing tank operates within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the mixing tank with agitator meets all performance criteria.
Maintenance Personnel: Ensures that the mixing tank with agitator is properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning correctly during the qualification process.

4) Procedure

The following steps should be followed for the IQ, OQ, and PQ of mixing tanks with agitators:

1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the mixing tank with agitator meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical power, compressed air, water, steam) are available and meet the specifications required for proper operation of the tank.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including the agitator system, motor, bearings, seals, and the tank body.
1.5 Ensure that all electrical components, including sensors, control systems, and alarms, are properly connected and functioning.
1.6 Perform a visual inspection to confirm that the equipment is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.

2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as mixing speed, temperature, agitation pressure, and tank pressure, are properly set and calibrated.
2.2 Conduct a dry run of the mixing tank with agitator to verify that it operates without issues. Monitor key parameters such as agitation speed, temperature stability, and consistency of the mixture.
2.3 Test all control systems, ensuring that the start/stop, speed controls, heating/cooling mechanisms, and emergency stop functions are working correctly.
2.4 Inspect the mixing process to ensure that the tank produces a homogeneous mixture and that there are no issues such as vortex formation, foam generation, or incomplete mixing.
2.5 Verify that the agitation system operates smoothly and consistently, with no signs of malfunction such as uneven mixing or excessive vibration.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.

3. Performance Qualification (PQ):
3.1 Conduct the mixing process using a product or simulated product (e.g., water or an inert solution) and monitor performance under typical production conditions.
3.2 Measure the uniformity of the mixture by performing sampling at different points in the tank and analyzing parameters such as consistency, pH, viscosity, and other quality indicators.
3.3 Verify that the mixing tank maintains the desired uniformity throughout the batch process and that the agitator produces consistent results across different production cycles.
3.4 Conduct an assessment of the system’s performance by ensuring that the mixing tank operates at the required throughput without compromising mixture quality.
3.5 Verify that the tank does not exhibit any mechanical issues, such as seal leakage, excessive heating, or agitator malfunction, during normal operation.
3.6 Document the results of the PQ, including sampling data, operational performance, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.

4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including batch records, equipment logs, process parameters, and inspection results for mixture consistency, temperature control, and system performance.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the mixing process. This analysis should confirm that the mixing tank operates consistently and meets the acceptance criteria for uniformity and product quality.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the mixing tank’s performance.

5. Requalification:
5.1 Requalify the mixing tank with agitator if significant changes are made to the equipment, such as replacing major components, relocating the tank, or modifying the agitation system.
5.2 Periodically perform requalification to ensure that the equipment continues to perform as expected and remains in compliance with regulatory requirements.

5) Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• SOP: Standard Operating Procedure

6) Documents

• IQ/OQ/PQ Protocol
• Equipment Manufacturer Specifications
• Installation and Setup Reports
• Calibration Records
• Mixing Process Records
• Sampling and Viscosity Test Logs
• Deviation and Corrective Action Reports

7) Reference

• FDA Guidance for Industry: Equipment Qualification
• International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• ISO 9001: Quality Management Systems – Requirements
• USP Chapter 1151: Pharmaceutical Dosage Forms

8) SOP Version

Version 1.0 – Effective Date: DD/MM/YYYY

Annexure

Template 1: IQ/OQ/PQ Test Record

Date	Time	Operator Initials	Test Type (IQ/OQ/PQ)	Test Results	Comments
DD/MM/YYYY	HH:MM	Operator Name	IQ/OQ/PQ	Pass/Fail	Comments

Template 2: Mixing Performance Log

Batch No.	Test Date	Mixing Time (minutes)	Viscosity (cP)	Uniformity (Pass/Fail)	Operator Initials
Batch Number	DD/MM/YYYY	Time	Viscosity	Pass/Fail	Operator Name

Template 3: Agitator Calibration and Maintenance Log

Equipment Name	Calibration Date	Maintenance Performed	Next Calibration Date	Operator Initials
Agitator Model	DD/MM/YYYY	Maintenance Tasks	DD/MM/YYYY	Operator Name