Standard Operating Procedure for Blister Packaging of Capsules

Department	Capsule Packaging
SOP No.	SOP/CP/201/2025
Supersedes	SOP/CP/201/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for blister packaging of capsules to ensure that capsules are packaged safely and in accordance with GMP standards.

2. Scope

This SOP applies to all blister packaging activities for capsules within the manufacturing facility. It includes procedures for preparing packaging materials, operating blister packaging machines, and ensuring the quality of the packaged product.

3. Responsibilities

• Packaging Operator: Responsible for operating the blister packaging machine and ensuring that capsules are properly placed in blisters.
• Quality Control (QC): Responsible for inspecting and verifying the integrity of the blister-packed capsules.
• Production Supervisor: Responsible for overseeing the blister packaging process and ensuring compliance with the SOP.

4. Accountability

The Production Manager is accountable for ensuring that blister packaging is performed according to this SOP, while the QC Manager ensures the quality of the packaged capsules.

5. Procedure

5.1 Pre-Packaging Preparation

Before starting the blister packaging process, ensure the following:

1. Prepare Blister Packaging Materials
   1. Ensure the availability of appropriate blister packs, foils, and labels. Verify that the packaging material is intact and free of defects.
2. Calibrate Packaging Machines
   1. Check and calibrate the blister packaging machine to ensure it is working within the required specifications for blister size, sealing temperature, and time.
3. Verify Product Specifications
   1. Review the batch records to verify the number of capsules to be packaged and ensure that the correct product is used.

5.2 Blister Packaging Process

Follow these steps for the blister packaging procedure:

1. Load Capsules into Packaging Machine
   1. Place the capsules into the appropriate loading area of the blister packaging machine. Ensure that the capsules are placed properly to avoid damage.
2. Operate the Blister Packaging Machine
   1. Start the machine, ensuring that the capsules are placed in the blister cavities. The machine will automatically form the blister pack, fill it with capsules, and seal the pack.
3. Inspect Packaging Quality
   1. Perform visual inspection of each blister to ensure that capsules are correctly placed, that there are no holes in the blister, and that seals are intact.
4. Check Date and Lot Code
   1. Ensure that the blister packs are printed with the correct batch number, manufacturing date, and expiry date. Verify that the lot number is printed correctly.

5.3 Post-Packaging Activities

After packaging the capsules, ensure the following:

1. Inspect and Reject Defective Blisters
   1. Inspect each blister for any defects such as holes, incomplete seals, or damaged capsules. Reject any defective blisters for rework or disposal.
2. Store Packaged Capsules
   1. Once the packaging is complete and inspected, store the blister packs in the appropriate storage area, ensuring that they are kept under suitable environmental conditions.
3. Record Packaging Data
   1. Document all relevant packaging details, including the number of blisters produced, any deviations, and the results of the visual inspection. Store records in compliance with GMP standards.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• EP: European Pharmacopoeia
• USP: United States Pharmacopeia

7. Documents

1. Annexure 1: Blister Packaging Log
2. Annexure 2: QC Inspection Report
3. Annexure 3: Packaging Equipment Calibration Log

8. References

• USP <701> – Disintegration of Tablets and Capsules
• European Pharmacopoeia 2.9.1 – Dissolution Testing
• Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Blister Packaging Log

Batch ID	Packaging Date	Number of Capsules	Blister Pack Type	Operator	Comments
Batch 014	02/02/2025	100,000	Standard	John Doe	No defects

Annexure 2: QC Inspection Report

Batch ID	Inspection Date	Defects Identified	Corrective Actions	Final Outcome
Batch 014	02/02/2025	None	None	Approved

Annexure 3: Packaging Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Blister Machine 501	01/02/2025	John Doe	Calibration of blister pack size	01/02/2026

12. Revision History

Revision Date	Revision No.	Revision Details	Annexure 3: Packaging Equipment Calibration Log Equipment ID Calibration Date Operator Calibration Details Next Calibration Due Blister Machine 501 01/02/2025 John Doe Calibration of blister pack size 01/02/2026 12. Revision History Revision Date Revision No. Revision Details Reason for Revision Approved By 01/01/2024 1.0 Initial version of SOP Creation of SOP for blister packaging QA Head 01/02/2025 2.0 Updated equipment calibration details and packaging process Process optimization QA Head See also  Capsule: SOP for Ensuring Dispensing Accuracy Using Barcode Scanning - V 2.0 Exit mobile version