Standard Operating Procedure for Deblistering Process

Purpose

The purpose of this SOP is to establish procedures for the safe and effective deblistering of pharmaceutical products, ensuring the recovery of intact tablets or capsules for quality control purposes.

Scope

This SOP applies to all personnel involved in the deblistering process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing the deblistering process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining deblistering equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for inspecting and assessing the quality of recovered tablets or capsules.

Procedure

1. Inspect the deblistering equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the deblistering process.
3. Verify that the blister packs to be deblistered are properly labeled and approved for use.
4. Load the blister packs into the deblistering machine, adjusting the settings according to the blister pack specifications.
5. Initiate the deblistering process and monitor the machine to ensure the recovery of intact tablets or capsules.
6. Perform periodic checks on the recovered tablets or capsules to ensure quality and integrity.
7. If adjustments to the deblistering parameters are necessary, document the changes made and the reason for the adjustments.
8. Transfer the recovered tablets or capsules to the quality control area for inspection and testing.
9. Perform quality control tests on the recovered tablets or capsules, including visual inspection, weight verification, and any additional tests required.
10. Document the results of the quality control tests, noting any deviations from the standard specifications.
11. If the recovered tablets or capsules pass quality control, release them for further processing or analysis.
12. If the recovered tablets or capsules fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
13. Complete the logbook or batch record with all pertinent information, including any adjustments made during the deblistering process.
14. Clean and sanitize the deblistering equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Deblistering Logbook
• Quality Control Test Results
• Maintenance and Calibration Records
• Deviation and Corrective Action Logs

Reference

USP General Chapter <1216> – Tablet Friability

SOP Version

Version 1.0