Standard Operating Procedure for Qualification of Syrup Manufacturing Tanks
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying syrup manufacturing tanks used in pharmaceutical manufacturing. This SOP ensures that the syrup manufacturing tanks are correctly installed, operate according to specifications, and perform consistently under normal production conditions. The qualification process verifies the mechanical, electrical, and operational parameters of the syrup manufacturing tanks, ensuring that the syrups produced meet the required regulatory and quality standards, including uniformity, stability, and homogeneity.
2) Scope
This SOP applies to the qualification of all syrup manufacturing tanks used in the pharmaceutical industry for preparing syrups, suspensions, and other liquid dosage forms. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new syrup manufacturing tanks and those that have undergone major repairs, upgrades, or relocations. The qualification ensures that the tank operates effectively and complies with regulatory requirements for product quality.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the syrup manufacturing tank is operated according to the qualification protocols and that critical parameters are monitored during testing.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the 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 syrup manufacturing tank meets all performance criteria.
Maintenance Personnel: Ensures that the syrup manufacturing tank 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 syrup manufacturing tanks:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the syrup manufacturing tank meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical power, steam, water supply, compressed air) 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 are correctly installed, including the mixing mechanisms, heating and cooling systems, and product transfer systems.
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 temperature, mixing speed, and tank pressure, are properly set and calibrated.
2.2 Conduct a dry run of the syrup manufacturing tank to verify that it operates without issues. Monitor key parameters such as liquid flow, mixing efficiency, temperature uniformity, and pressure control.
2.3 Test all control systems, ensuring that the start/stop, temperature controls, agitation systems, and emergency stop functions work correctly.
2.4 Inspect the syrup manufacturing process to ensure that it produces uniform, homogenous mixtures and meets predefined quality standards.
2.5 Perform calibration checks to verify that the temperature, agitation, and filling controls are within the specified limits.
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 syrup manufacturing process using product or simulated product (e.g., water with added colors) and monitor performance under typical production conditions.
3.2 Measure the temperature distribution within the syrup tank to verify uniform heating or cooling during the process.
3.3 Perform a test to verify the mixing efficiency by sampling from various points within the syrup tank to confirm uniformity.
3.4 Verify that the mixing process does not introduce air bubbles or cause separation of ingredients, ensuring that the syrup remains homogeneous throughout the process.
3.5 Perform visual inspections of the syrup produced to ensure there are no impurities, clumping, or other inconsistencies in the formulation.
3.6 Document the results of the PQ, including temperature profiles, mixing consistency, 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 temperature, mixing, and product quality.
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 syrup manufacturing process. This analysis should confirm that the tank operates efficiently and meets predefined standards for syrup 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 syrup manufacturing tank’s performance.
5. Requalification:
5.1 Requalify the syrup manufacturing tank if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the 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
- Syrup Manufacturing Process Records
- Temperature and Mixing 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: Syrup Manufacturing Log
| Batch No. | Test Date | Temperature (°C) | Mixing Speed (RPM) | Consistency (Pass/Fail) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Temperature | Speed | Pass/Fail | Operator Name |
Template 3: Temperature and Mixing Record Log
| Batch No. | Test Date | Temperature (°C) | Mixing Time (minutes) | Result | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Temperature | Time | Pass/Fail | Operator Name |