Standard Operating Procedure for Qualification of Tablet Dedusters
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying tablet dedusters used in pharmaceutical manufacturing. This SOP ensures that tablet dedusters, which are used to remove excess powder from tablets after compression, are installed, operated, and perform according to specifications. The qualification process includes verifying the mechanical, electrical, and operational parameters of the deduster to ensure it performs effectively under normal production conditions and meets the required quality and regulatory standards.
2) Scope
This SOP applies to the qualification of tablet dedusters used in pharmaceutical manufacturing for removing excess dust or powder from tablets after the compression process. It includes the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of tablet dedusters. The SOP is applicable to both new dedusters and those that have undergone repairs, modifications, or relocations. The qualification process ensures that the deduster operates within defined parameters to meet quality requirements for tablet cleanliness and presentation.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the tablet deduster is operated in compliance with the qualification protocols and that critical parameters are monitored
Quality Assurance (QA): Ensures that the qualification of the tablet deduster is performed according to this SOP and meets 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 deduster 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 deduster meets all performance criteria.
Maintenance Personnel: Ensures that the tablet deduster 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 tablet dedusters:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the tablet deduster meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical, compressed air, etc.) are available and meet the specifications required for proper operation of the deduster.
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 tablet conveyor, dust collection system, and air filtration system, are correctly installed.
1.5 Ensure that all electrical components, including sensors, controls, 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 conveyor speed, air pressure, and dust removal settings, are properly set and calibrated.
2.2 Conduct a dry run of the tablet deduster to verify that it operates without issues. Monitor key parameters such as airflow, vibration, and noise levels during operation.
2.3 Test all control systems, ensuring that the start/stop functions, air pressure controls, and reject mechanisms are working correctly.
2.4 Inspect the operation to ensure that the deduster removes the dust effectively without causing damage to the tablets. Ensure that the air pressure is consistent and that the dust collection system functions properly.
2.5 Check for any tablet breakage, abrasion, or other defects caused by the dedusting process.
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 dedusting process using product tablets (either batch or simulated) and monitor performance under typical production conditions.
3.2 Perform sampling during the dedusting cycle to measure the amount of dust removed from the tablets and ensure that the product meets cleanliness specifications.
3.3 Measure the throughput of the deduster and ensure that it operates efficiently, removing dust without compromising tablet integrity or production speed.
3.4 Perform visual inspection to ensure that the tablets are free from excess powder and that they meet the predefined appearance standards.
3.5 Verify that the deduster is not causing any damage to the tablets, such as breakage, chips, or uneven coatings.
3.6 Document the results of the PQ, including dust removal efficiency, any process deviations, and corrective actions taken. 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 cleanliness, dust removal efficiency, and tablet integrity.
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 dedusting process. This analysis should confirm that the deduster operates efficiently and meets the acceptance criteria.
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 deduster’s performance.
5. Requalification:
5.1 Requalify the tablet deduster if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the dust collection 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
- Dedusting Process Records
- Tablet Inspection and Cleanliness Logs
- Rejection 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: Dedusting Efficiency Log
| Batch No. | Test Date | Dust Removal Efficiency (%) | Tablet Integrity (Pass/Fail) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Efficiency in % | Pass/Fail | Operator Name |
Template 3: Tablet Inspection Log
| Batch No. | Inspection Date | Defect Type | Pass/Fail | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Defect Type | Pass/Fail | Operator Name |
