is responsible for reviewing and approving the qualification reports and documentation.
Production Supervisors: Oversee the qualification processes, ensuring that operators follow the protocol and the equipment operates within specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the blenders meet performance criteria.
Maintenance Personnel: Ensures that the blenders are properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning as required during the qualification process.

4) Procedure

The following steps should be followed for the IQ, OQ, and PQ of Ribbon and V-Blenders:

1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the blender meets installation requirements.
1.2 Ensure that all necessary utilities (electrical, air, etc.) are available and meet the specified requirements for proper equipment operation.
1.3 Verify that the installation site meets the required environmental conditions, such as cleanliness, temperature, and humidity.
1.4 Confirm that all mechanical components are correctly installed, including the motor, drive system, paddles, and seals.
1.5 Ensure that all electrical components are installed properly and that control systems, alarms, and emergency stops are functional.
1.6 Perform a visual inspection to confirm that the equipment is installed according to the manufacturer’s instructions and regulatory requirements.
1.7 Complete the IQ documentation, including checklists and equipment manuals, and ensure that all information is recorded and signed by responsible personnel.

2. Operational Qualification (OQ):
2.1 Verify that all operational controls and settings, such as motor speed, mixing time, and operating temperature (if applicable), are properly set and calibrated.
2.2 Conduct an empty run to verify that the blender operates without issues, and monitor key parameters like motor function, vibrations, and noise levels.
2.3 Test all control systems, ensuring that start/stop, mixing speed, and emergency stop buttons function properly.
2.4 Check for uniformity in the mixing process during operation. Verify that the blending process does not result in material segregation, excessive dust, or clumping.
2.5 Verify the functionality of the mixing mechanism, ensuring that the blades or paddles rotate smoothly and that there is no obstruction or wear.
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 blending process using product or simulated product (such as inert powder) and monitor the performance under typical production conditions.
3.2 Measure the uniformity of the mix, checking the homogeneity of the blend after a fixed period of mixing. Ensure that the product meets predefined specifications for uniformity.
3.3 Perform sampling during the blending cycle to ensure consistent blending performance. Use techniques such as sample testing for particle size distribution, moisture content, or blending time consistency.
3.4 Evaluate the blending efficiency by comparing the results of blend uniformity and homogeneity against predefined criteria.
3.5 Document the results of the PQ, including sample results, any process deviations, and the corrective actions taken. Ensure that all records are signed and reviewed by responsible personnel.

4. Documentation and Reporting:
4.1 Complete the IQ, OQ, and PQ protocols, ensuring that all required tests are performed, results are recorded, and deviations are documented.
4.2 Review the IQ, OQ, and PQ reports for accuracy, completeness, and compliance with applicable regulatory requirements.
4.3 Maintain all documentation in accordance with internal quality management procedures and regulatory guidelines.
4.4 Ensure that the equipment is properly documented and signed off by all responsible personnel, including operators, supervisors, maintenance, and QA.
4.5 Prepare a final qualification report, summarizing the results of IQ, OQ, and PQ, including any corrective actions and conclusions.

5. Requalification:
5.1 Requalify the blenders if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying control systems.
5.2 Perform periodic 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
• Blending Process Records
• Blend Uniformity Test Records
• Deviations and Corrective Action Logs

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: Blending Performance Test Log

Test Date	Blend Uniformity	Particle Size Distribution	Moisture Content	Pass/Fail	Operator Initials
DD/MM/YYYY	Pass/Fail	Test Method	Moisture Percentage	Pass/Fail	Operator Name

Template 3: Equipment Calibration and Maintenance Log

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