Standard Operating Procedure for Tablet Inspection Process
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for the systematic and controlled inspection of tablets to ensure their quality, integrity, and compliance with specifications. This SOP aims to identify and eliminate any defective tablets before packaging and distribution.
2. Scope
This SOP applies to all personnel involved in the tablet inspection process, including operators, inspectors, and quality assurance staff, in the manufacturing and quality control departments.
3. Responsibilities
- Tablet Inspection Operator: Responsible for conducting the tablet inspection process following this SOP and reporting any deviations or issues.
- Quality Control (QC) Inspector: Responsible for overseeing the inspection process, verifying compliance with this SOP, and conducting periodic checks to ensure inspection accuracy.
- Production Supervisor: Responsible for supervising the tablet inspection process and addressing any operational concerns.
4. Procedure
4.1 Pre-Inspection Preparation:
- Ensure that the tablet inspection machine is clean, calibrated, and set to the correct inspection parameters as specified in the batch record.
- Verify that the appropriate lighting and magnification settings are adjusted for optimal inspection visibility.
- Review the batch record and product specifications to understand the acceptance criteria and any specific requirements for the tablets being inspected.
- Prepare the necessary documentation, inspection logs, and recording sheets to document the inspection process.
4.2 Tablet Inspection:
- Start 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.
- Initiate the inspection process, and monitor the tablets as they pass through the machine for defects, such as chips, cracks, discoloration, and size variation.
- Inspect the tablets according to the acceptance criteria, and categorize them as accepted or rejected based on their condition.
- If any defective tablets are identified, use the appropriate rejection process, and collect the rejected tablets separately for further investigation and disposition.
4.3 Post-Inspection Checks:
- After completing the inspection process, review the inspection data and ensure that the number of accepted tablets meets the required quality standards.
- Document the inspection results, including the number of accepted and rejected tablets, along with any observations made during the inspection.
- 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
QC: Quality Control
6. Documents
The following documents are relevant to this SOP:
- Batch Record for the tablets being inspected
- Machine Calibration and Maintenance Log
- Inspection Data Recording Sheets
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 Tablet Inspection Process, effective as of [Insert Date].