Standard Operating Procedure for Capsule Shell Inspection

Purpose

The purpose of this SOP is to establish procedures for the systematic and thorough inspection of capsule shells in pharmaceutical manufacturing, ensuring compliance with regulatory standards and maintaining product quality.

Scope

This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical capsules, including operators, inspectors, and quality control personnel.

Responsibilities

• Operators: Responsible for executing procedures related to the production of capsule shells and initial visual inspection.
• Inspectors: Responsible for detailed visual inspections of finished capsule shells.
• Quality Control Personnel: Responsible for monitoring and verifying capsule shell inspections for compliance.

Procedure

1. Ensure that the capsule manufacturing equipment is clean, calibrated, and set up according to the approved process parameters.
2. Verify the quality and specifications of raw materials used in the capsule shell production process.
3. During capsule shell production, monitor and document key process parameters, including but not limited to temperature, humidity, and drying times.
4. Inspect the appearance of capsule shells during the production process for any visible defects, such as discoloration, cracks, or deformities.
5. Collect samples at specified intervals during capsule production for subsequent detailed visual inspection.
6. For detailed visual inspection, use appropriate lighting and magnification tools to evaluate the capsule shell surface for defects.
7. Record the results of capsule shell inspections, including any deviations from the predefined specifications, in the designated logbook or electronic system.
8. If defects are identified during visual inspection, segregate and document affected units, and initiate an investigation to determine the root cause.
9. Implement corrective actions based on the findings of the investigation to prevent the recurrence of defects.
10. For finished batches, ensure that the required sampling plan for capsule shell inspection is followed, and document the results accordingly.
11. Document any out-of-specification (OOS) results, initiate an investigation, and implement corrective actions as needed.
12. Archive capsule shell inspection records in accordance with established retention policies.
13. Regularly review and update capsule shell inspection procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Capsule Shell Inspection Logbook
• Calibration Records
• Validation Reports
• Deviation and Corrective Action Logs

Reference

USP General Chapter <1174> – Pharmaceutical Dosage Forms

SOP Version

Version 1.0