Standard Operating Procedure for Blister Packaging Process

Purpose

The purpose of this SOP is to establish procedures for the blister packaging of pharmaceutical products, ensuring the packaging process is consistent, meets quality standards, and complies with regulatory requirements.

Scope

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

Responsibilities

• Operators: Responsible for executing the blister packaging process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining blister packaging equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the blister packaging SOP.

Procedure

1. Inspect the blister packaging 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 blister packaging process.
3. Verify that all materials, including blister packs and product inserts, are properly labeled and approved for use.
4. Set up the blister packaging machine according to the approved specifications for product size, blister type, and packaging configuration.
5. Load the product into the blister packs and place any necessary inserts or documentation.
6. Adjust the sealing parameters on the machine, including temperature and pressure, according to the approved specifications.
7. Initiate the blister packaging process and monitor the machine to ensure uniform sealing and adherence to specified parameters.
8. Perform periodic checks on the blister packs to ensure proper sealing, product placement, and package integrity.
9. If adjustments to the packaging parameters are necessary, document the changes made and the reason for the adjustments.
10. Perform in-process checks, such as visual inspections and weight verifications, to assess the quality of the packaged products.
11. Collect samples for quality control testing, including packaging integrity and appearance.
12. Submit samples to the quality control laboratory, ensuring that the blister-packaged products meet the predefined acceptance criteria.
13. If the products pass quality control, proceed with further processing steps as per the formulation requirements.
14. If the products fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
15. Complete the logbook or batch record with all pertinent information, including any adjustments made during the blister packaging process.
16. Clean and sanitize the blister packaging equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

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

Reference

FDA Code of Federal Regulations – Title 21

SOP Version

Version 1.0