Standard Operating Procedure for Capsule Inspection

Purpose

The purpose of this SOP is to establish procedures for the visual inspection and quality control of capsules, ensuring adherence to quality standards, and the identification of defects or deviations.

Scope

This SOP applies to all personnel involved in the capsule inspection process, including inspectors, quality control personnel, and supervisors.

Responsibilities

• Inspectors: Responsible for visually inspecting capsules according to the established procedures.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the capsule inspection SOP.
• Supervisors: Responsible for overseeing the capsule inspection process and providing necessary support to inspectors.

Procedure

1. Ensure that the capsule inspection area is clean, well-lit, and free from any potential contaminants.
2. Verify that the inspection equipment, such as magnifying glasses or automated inspection machines, is calibrated and functioning correctly.
3. Inspect the capsules visually for any defects, including but not limited to cracks, discoloration, and irregularities in size or shape.
4. Set up any necessary magnification equipment to aid in the detailed inspection of capsules.
5. Sort the inspected capsules into accepted and rejected categories based on the predefined acceptance criteria.
6. If using automated inspection machines, ensure that the equipment is programmed with the correct inspection parameters.
7. Perform periodic checks on the automated inspection machine to ensure accurate and consistent results.
8. If defects are identified, document the type and number of defects found, and initiate the appropriate corrective actions.
9. Record the inspection results, including the number of accepted and rejected capsules, in the inspection log or batch record.
10. Submit rejected capsules to the quality control laboratory for further analysis if required.
11. If adjustments to the inspection process are necessary, document the changes made and the reason for the adjustments.
12. Report any trends or recurring issues in capsule defects to the quality control department for investigation and resolution.
13. Complete the logbook or batch record with all pertinent information, including any adjustments made during the capsule inspection process.
14. Clean and sanitize the inspection area and equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Capsule Inspection Logbook
• Quality Control Test Results
• Deviation and Corrective Action Logs

Reference

USP General Chapter <797> – Pharmaceutical Compounding – Sterile Preparations

SOP Version

Version 1.0