1) SOP for Blister Packaging

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the setup and operation of blister packaging machines to ensure consistent and compliant packaging of pharmaceutical products.

3) Scope

This SOP applies to all blister packaging activities performed at the company’s manufacturing facility, including the handling of packaging materials and the operation of blister packaging machines.

4) Responsibilities

• Production Department: Responsible for setting up and operating blister packaging machines according to this SOP.
• Quality Assurance (QA) Department: Responsible for ensuring compliance with quality standards and regulatory requirements during blister packaging.
• Engineering Department: Responsible for maintenance and calibration of blister packaging machines.
• Warehouse/Logistics: Responsible for handling and storing packaging materials.

5) Procedure

1. Preparation and Setup
   1. Verify availability and condition of packaging materials (blister packs, foil, etc.).
   2. Set up the blister packaging machine according to machine-specific procedures and manufacturer’s instructions.
   3. Perform equipment checks and ensure all components (feeders, printers, detectors) are calibrated and functioning properly.
2. Packaging Operations
   1. Load packaging materials into the machine feeders and adjust settings for batch specifications.
   2. Initiate packaging process and monitor machine operation for consistency and quality.
   3. Perform in-process checks to verify correct blister formation, sealing integrity, and printing quality.
3. Machine Cleaning and Maintenance
   1. Clean blister packaging machine before and after each batch using approved cleaning procedures and agents.
   2. Perform routine maintenance tasks as per machine maintenance schedule to ensure optimal performance.
   3. Calibrate machine components (temperature, pressure, sensors) as required and document calibration activities.
4. Handling of Packaging Materials
   1. Store packaging materials in designated areas with appropriate labeling and segregation.
   2. Inspect incoming packaging materials for damage or discrepancies and quarantine if necessary.
   3. Document receipt, usage, and disposal of packaging materials according to company procedures.
5. Documentation and Record Keeping
   1. Record all blister packaging activities, including machine setup, operations, cleaning, maintenance, and material handling.
   2. Maintain batch records, equipment logs, and other documentation as per regulatory requirements.
   3. Archive records and documents for future reference and regulatory inspections.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Blister Packaging Machine Setup Checklist
• Batch Records
• Cleaning and Maintenance Logs
• Material Handling Records

8) Reference, if any

• Good Manufacturing Practice (GMP) Guidelines
• Company-specific blister packaging procedures and guidelines

9) SOP Version

Version 1.0