Standard Operating Procedure for Operation of Tablet Inspection Machine
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide step-by-step guidelines for the proper operation of the tablet inspection machine. This SOP ensures that tablets are thoroughly inspected for defects and conformity with quality standards before packaging and distribution.
2. Scope
This SOP applies to all personnel involved in the operation of the tablet inspection machine, including operators and quality assurance staff, in the manufacturing department.
3. Responsibilities
- Tablet Inspection Machine Operator: Responsible for operating the tablet inspection machine as per this SOP and reporting any issues or abnormalities during the inspection process.
- Quality Assurance (QA) Staff: Responsible for overseeing the tablet inspection process, ensuring compliance with this SOP, and conducting periodic checks to verify the accuracy of inspections.
- Production Supervisor: Responsible for supervising the operation of the tablet inspection machine and addressing any operational concerns.
4. Procedure
4.1 Preparation for Inspection:
- Ensure that the tablet inspection machine is clean and free from any residual material from the previous inspection.
- Verify that the machine is calibrated and set to the appropriate inspection parameters as specified in the batch record.
- Check that the appropriate rejection and ejection systems are in place and functioning correctly.
- Review the batch record to understand the inspection criteria and any specific requirements for the tablets being inspected.
4.2 Operation of Tablet Inspection Machine:
- Turn on the tablet inspection machine and allow it to warm up, following the manufacturer’s guidelines.
- Load the tablets into the machine’s feed system carefully, ensuring proper alignment and distribution for accurate inspection.
- Start the inspection process according to the set parameters, allowing the machine to inspect the tablets for defects, such as chipping, cracks, discoloration, and size variation.
- Monitor the inspection process continuously, watching for any irregularities or machine malfunctions.
- If the machine detects any defective tablets, follow the appropriate rejection process, and collect the rejected tablets separately for further investigation.
4.3 Post-Inspection Checks:
- After the inspection process is complete, review the inspection data and ensure that the number of accepted tablets meets the required quality standards.
- Collect and document the inspection data, including the number of accepted and rejected tablets, as well as any comments or observations during the inspection process.
- Perform a visual check of the machine’s interior and exterior to ensure there are no loose parts, debris, or contamination.
- Shut down the tablet inspection machine following the proper shutdown procedure.
5. Abbreviations
SOP: Standard Operating Procedure
QA: Quality Assurance
6. Documents
The following documents are relevant to this SOP:
- Batch Record for the tablets being inspected
- Machine Calibration and Maintenance Log
- Rejection and Ejection System Guidelines
7. References
No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.
8. SOP Version
This is version 1.0 of the SOP for Operation of Tablet Inspection Machine, effective as of [Insert Date].