Standard Operating Procedure for IQ/OQ/PQ of Automatic Tablet Inspection Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of automatic tablet inspection machines used in pharmaceutical manufacturing. This SOP ensures that the tablet inspection machine is correctly installed, operates as specified, and performs consistently under normal production conditions. The qualification process verifies the accuracy, efficiency, and reliability of the inspection machine in detecting defective tablets, ensuring that only high-quality tablets are released for packaging.
2) Scope
This SOP applies to the qualification of automatic tablet inspection machines used for detecting defects in tablets, such as cracks, chips, discoloration, weight deviations, and improper coating. It covers the IQ, OQ, and PQ stages of qualification, ensuring that the equipment is installed properly, operates according to specifications, and performs effectively to meet the required quality standards. This SOP is applicable to both new machines and those that have undergone major repairs, upgrades, or relocations.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the inspection machine is operated according to the qualification protocols and that critical parameters are monitored and recorded during testing.
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the automatic tablet inspection machine are carried out in compliance with this SOP and meet all regulatory requirements. QA is 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 machine 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 inspection machine meets all performance criteria.
Maintenance Personnel: Ensures that the inspection machine 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 automatic tablet inspection machines:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the tablet inspection machine meets the necessary requirements for installation.
1.2 Verify that all necessary utilities (e.g., electrical power, compressed air, etc.) are available and meet the specifications required for proper machine operation.
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, including the conveyor system, cameras, lighting, and reject mechanisms, are correctly installed.
1.5 Ensure that all electrical components, including sensors, controllers, 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 regulatory requirements.
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, including tablet feed rate, camera sensitivity, reject mechanism, and alarm settings, are properly set and calibrated.
2.2 Conduct a dry run of the tablet inspection machine to verify that it operates without issues. Monitor key parameters such as camera focus, lighting conditions, and alignment of tablets on the conveyor.
2.3 Test all control systems, ensuring that the start/stop, speed controls, tablet detection, reject mechanisms, and emergency stop functions are working correctly.
2.4 Inspect the inspection process to ensure that tablets are being accurately inspected for defects. Verify that defective tablets (e.g., chipped, cracked, or improperly coated) are identified and rejected.
2.5 Perform calibration checks to ensure that the camera sensitivity and defect detection algorithms are properly set.
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 inspection process using product tablets (either batch or simulated) to monitor performance under normal production conditions.
3.2 Perform sampling during the inspection cycle to measure the accuracy of defect detection and rejection rates. Ensure that defective tablets are detected and rejected accurately and that the system does not falsely reject good tablets.
3.3 Verify that the inspection machine operates at the required throughput without affecting defect detection accuracy or efficiency.
3.4 Perform sensitivity testing by introducing different types of defects, such as cracks, chips, discoloration, and improper coating, to ensure that the machine detects all relevant defects.
3.5 Conduct a final inspection to ensure that the system does not generate false positives or fail to identify defective tablets.
3.6 Document the results of the PQ, including defect detection accuracy, rejection rates, 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 tablet defect detection, reject rates, 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 tablet inspection process. This analysis should confirm that the machine operates consistently and detects defects with the required accuracy.
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 tablet inspection machine’s operational capabilities.
5. Requalification:
5.1 Requalify the automatic tablet inspection machine if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the inspection 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
- Inspection Process Records
- Defect Detection Test Logs
- Rejection Rate Records
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: Defect Detection and Rejection Log
| Batch No. | Test Date | Defect Type | Detection Rate | Rejection Rate | Pass/Fail | Operator Initials |
|---|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Defect Type | Detection Rate (%) | Rejection Rate (%) | Pass/Fail | Operator Name |
Template 3: Inspection Machine Calibration and Maintenance Log
| Equipment Name | Calibration Date | Maintenance Performed | Next Calibration Date | Operator Initials |
|---|---|---|---|---|
| Inspection Machine Model | DD/MM/YYYY | Maintenance Tasks | DD/MM/YYYY | Operator Name |
