Standard Operating Procedure for Performance Qualification (PQ) of Tablet Coating Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for performing Performance Qualification (PQ) of tablet coating machines in pharmaceutical manufacturing. This SOP ensures that the tablet coating machine operates consistently under typical production conditions and meets all performance criteria. The PQ process verifies that the equipment consistently delivers coated tablets that meet predefined quality attributes such as coating uniformity, thickness, and durability. The successful completion of PQ ensures that the coating process can reliably produce products that meet regulatory requirements and quality standards.
2) Scope
This SOP applies to the performance qualification of all tablet coating machines used in pharmaceutical manufacturing for coating tablets with sugar, film, or enteric coatings. It includes the verification of critical operational parameters during normal production runs, including coating uniformity, spray rate, temperature control, and tablet throughput. This SOP is applicable to both new tablet coating machines and existing machines that have undergone major repairs, upgrades, or modifications.
3) Responsibilities
Operators: Responsible for operating the tablet coating machine according to the validated protocol, ensuring that all critical process parameters are monitored and recorded
Quality Assurance (QA): Ensures that the performance qualification of the tablet coating machine complies with this SOP and meets all regulatory requirements. QA is responsible for reviewing and approving all PQ documentation and reports.
Production Supervisors: Oversee the PQ process to ensure that operators follow established protocols and that the coating machine operates within the defined parameters.
Validation Team: Responsible for developing and executing the Performance Qualification protocol, ensuring that all system components are verified under typical production conditions.
Maintenance Personnel: Ensures that the tablet coating machine is properly maintained and that all relevant components, such as spray guns, temperature controls, and exhaust systems, are functioning correctly during PQ testing.
4) Procedure
The following steps should be followed for the Performance Qualification (PQ) of tablet coating machines:
1. Preparation for PQ:
1.1 Review equipment manuals and specifications to ensure that the tablet coating machine meets the necessary requirements for performance qualification.
1.2 Confirm that the equipment is installed correctly and has passed Installation Qualification (IQ) and Operational Qualification (OQ).
1.3 Ensure that all necessary utilities, including compressed air, electrical power, and temperature control systems, are available and meet the specifications required for machine operation.
1.4 Verify that the environmental conditions (e.g., temperature and humidity) in the coating area meet the specified requirements for coating operations.
1.5 Prepare the batch records, product formulation (coating material), and packaging materials in compliance with product specifications.
1.6 Confirm that the operators have been trained in the PQ protocol and understand the critical parameters to be monitored during testing.
2. PQ Protocol Design:
2.1 Protocol Development: The PQ protocol should include objectives, scope, equipment parameters to be verified, and the criteria for success. The protocol should outline the steps to verify coating uniformity, coating thickness, spray rate, drying time, and tablet throughput.
2.2 Critical Parameters: Identify and define the critical operational parameters for the tablet coating machine, such as inlet temperature, exhaust temperature, coating spray rate, tablet rotation speed, and bed humidity.
2.3 Acceptance Criteria: Establish acceptance criteria for critical parameters to ensure that the tablet coating process is consistent and results in uniform coating and product quality. Acceptance criteria may include uniformity of coating thickness, tablet appearance, moisture content, and coating adhesion.
2.4 Risk Assessment: Perform a risk assessment to identify any potential issues related to coating consistency, spray system malfunction, or other factors that may affect the quality of the coated tablets. The assessment should guide the testing process and define areas of concern for the PQ process.
3. Execution of PQ:
3.1 Coating Equipment Setup: Set up the tablet coating machine according to the protocol, ensuring that all components such as spray guns, coating drums, and air handling systems are in place and functioning properly.
3.2 Coating Process Execution: Begin the coating process, ensuring that the correct formulation is applied to the tablets. Monitor key parameters such as tablet speed, spray rate, and drying temperature during the process.
3.3 Coating Uniformity: Perform visual and physical inspections of the coated tablets to verify coating uniformity and consistency. Ensure that the coating is applied evenly across the tablet surface and that there are no areas of under-coating or over-coating.
3.4 Coating Thickness Measurement: Measure the coating thickness at multiple points on the tablet surface using appropriate methods, such as micrometers or optical scanners. Verify that the coating thickness meets the predefined specifications for the product.
3.5 Drying Efficiency: Monitor the drying process by measuring the moisture content of the coated tablets. Ensure that the drying temperature and airflow rate are properly controlled to achieve the desired moisture level without causing damage to the tablets.
3.6 Tablet Inspection: Perform a detailed inspection of the tablets for physical defects such as chipping, discoloration, or cracking. Ensure that the tablets have a smooth, uniform coating with no defects that could affect product quality.
3.7 Spray Rate and Tablet Throughput: Measure the spray rate (volume of coating applied per minute) and tablet throughput (number of tablets processed per unit of time). Ensure that these parameters are consistent and meet the predefined criteria for efficient coating operations.
4. Documentation and Reporting:
4.1 Record all data during the PQ process, including batch records, equipment logs, process parameters, and inspection results for coating uniformity, coating thickness, spray rate, tablet throughput, and moisture content.
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 coating process. This analysis should confirm that the process consistently produces tablets that meet the acceptance criteria.
4.4 Prepare a final PQ report summarizing the results of the performance qualification, including any deviations, corrective actions, and conclusions regarding the tablet coating machine’s operational capabilities.
5. Requalification:
5.1 Requalify the tablet coating machine if significant changes are made to the equipment, such as modifications to critical components, or if the machine is relocated.
5.2 Periodically perform requalification tests to ensure that the equipment remains in proper working order and continues to operate within the defined specifications.
5) Abbreviations
- QA: Quality Assurance
- OQ: Operational Qualification
- PQ: Performance Qualification
- SOP: Standard Operating Procedure
- API: Active Pharmaceutical Ingredient
6) Documents
- Performance Qualification Protocol
- Equipment Manufacturer Specifications
- Coating Process Reports
- Tablet Inspection Reports
- Spray Rate and Throughput Logs
- Moisture Content Test Records
- Coating Thickness Measurement 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: PQ Test Record
| Date | Time | Operator Initials | Spray Rate (mL/min) | Coating Thickness (µm) | Moisture Content (%) | Tablet Appearance |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | Spray Rate in mL/min | Thickness in µm | Moisture Content in % | Pass/Fail |
Template 2: Coating Uniformity Inspection Log
| Batch No. | Inspection Date | Inspection Method | Result | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Test Method | Pass/Fail | Operator Name |
Template 3: Tablet Inspection Report
| Batch No. | Inspection Date | Defect Type | Pass/Fail | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Defect Type | Pass/Fail | Operator Name |
