Standard Operating Procedure for Capsule Polishing

Purpose

The purpose of this SOP is to establish procedures for the polishing of capsules, ensuring the removal of any surface imperfections, dust, or loose particles to meet quality standards.

Scope

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

Responsibilities

• Operators: Responsible for executing the capsule polishing process according to the established procedures.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the capsule polishing SOP.
• Supervisors: Responsible for overseeing the capsule polishing process and providing necessary support to operators.

Procedure

1. Ensure that the capsule polishing machine is clean, well-maintained, and calibrated before starting the polishing process.
2. Verify that all capsules to be polished are visually inspected for defects before entering the polishing machine.
3. Load the capsules into the polishing machine, ensuring proper spacing for effective polishing and preventing capsule damage.
4. Adjust the polishing parameters on the machine, including rotation speed and polishing time, according to the approved specifications.
5. Initiate the capsule polishing process and monitor the machine to ensure smooth operation and uniform polishing of capsules.
6. Perform periodic checks on polished capsules to ensure the removal of surface imperfections, dust, or loose particles.
7. If adjustments to the polishing parameters are necessary, document the changes made and the reason for the adjustments.
8. Inspect a sample of polished capsules for quality, including visual appearance and any potential defects introduced during the polishing process.
9. If defects are identified, document the type and number of defects found and initiate the appropriate corrective actions.
10. Record the polishing results, including the number of acceptable and rejected capsules, in the logbook or batch record.
11. Submit rejected capsules to the quality control laboratory for further analysis if required.
12. Report any trends or recurring issues in polished capsule quality 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 polishing process.
14. Clean and sanitize the polishing machine regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

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

Reference

USP General Chapter <797> – Pharmaceutical Compounding

SOP Version

Version 1.0