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