Capsule: SOP for Primary and Secondary Packaging of Capsules – V 2.0

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Capsule: SOP for Primary and Secondary Packaging of Capsules – V 2.0

Standard Operating Procedure for Primary and Secondary Packaging of Capsules

Department Capsule Packaging
SOP No. SOP/CP/206/2025
Supersedes SOP/CP/206/2022
Page No. Page 1 of 7
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP provides the procedure for the primary and secondary packaging of capsules, ensuring that they are packed in compliance with regulatory standards and GMP guidelines to protect the product’s integrity and prevent contamination.

2. Scope

This SOP applies to all activities related to the primary and secondary packaging of capsules, including the use of suitable packaging materials, packaging machines, labeling, and quality control during the packaging process.

3. Responsibilities

  • Packaging Operator: Responsible for operating packaging machinery, placing capsules into primary packaging materials (bottles, blister packs), and ensuring the correct placement of capsules and labels.
  • Quality Control (QC) Team: Ensures that the packaging process meets the defined specifications, including inspecting finished packages for accuracy and quality.
  • Production Supervisor: Oversees the entire packaging process and ensures that both primary and secondary packaging operations comply with SOP requirements.

4. Accountability

The Production Manager is responsible for ensuring that the primary and secondary packaging of capsules is completed in accordance with this SOP. The QC Manager ensures that all packaging complies with quality and regulatory standards.

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5. Procedure

5.1 Pre-Packaging Preparation

Before starting the packaging process, ensure the following:

  1. Verify Packaging Materials

    1. Ensure that all primary packaging materials (bottles, blister packs) and secondary packaging materials (cartons, labels) are available, intact, and meet the required specifications.
    2. Ensure that the packaging materials are labeled correctly and are free from defects.
  2. Check Capsule Batch

    1. Confirm that the correct batch of capsules is prepared for packaging, and verify that the batch number, quantity, and product details align with the Batch Production Record (BPR).
  3. Set Up Packaging Machines

    1. Ensure that the primary and secondary packaging machines are set up properly for the packaging process. This includes verifying machine parameters, such as filling volume and speed for capsule bottling or blister packing.

5.2 Primary Packaging Process

Follow these steps for primary packaging of capsules:

  1. Load Capsules into Packaging Line

    1. Load the capsules into the packaging machine according to the specified batch requirements. Ensure proper positioning of capsules for easy dispensing.
  2. Insert Capsules into Primary Packaging

    1. For bottle packaging, ensure that capsules are filled into bottles according to the specified count. For blister packaging, place capsules into each blister pocket using the blister pack machine.
  3. Seal Primary Packaging

    1. Ensure the correct sealing of bottles or blister packs to protect the capsules from contamination. Check for any damage or defects in the seals and correct any issues immediately.
  4. Label Primary Packaging

    1. Ensure that the labels are correctly applied to the primary packaging, displaying essential product information such as product name, batch number, expiry date, and any other regulatory information.
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5.3 Secondary Packaging Process

After the capsules are placed in their primary packaging, proceed with secondary packaging:

  1. Prepare Secondary Packaging Materials

    1. Ensure that secondary packaging materials (cartons, shrink wraps, etc.) are available and in good condition. Ensure that the cartons are appropriately sized for the bottles or blister packs.
  2. Package Primary Containers into Secondary Packaging

    1. Place the sealed bottles or blister packs into the secondary packaging (cartons, trays, etc.), ensuring that the items are positioned correctly to avoid damage.
  3. Seal Secondary Packaging

    1. Seal the secondary packaging appropriately (e.g., carton sealing, shrink wrapping) to ensure the integrity of the packaged product.
  4. Label Secondary Packaging

    1. Apply the secondary packaging label, ensuring that it contains all necessary information, such as product details, batch number, and quantity.

5.4 Post-Packaging Activities

After completing the packaging process, ensure the following:

  1. Final Inspection

    1. Perform a final inspection of the packaged products to ensure that all capsules are correctly packaged, sealed, and labeled according to specifications.
  2. Store Packaged Products

    1. Store the packaged capsules in an appropriate storage area, ensuring that they are protected from environmental factors such as humidity, temperature, and light.
  3. Record Packaging Data

    1. Document the packaging process, including the number of capsules packaged, any deviations encountered, and the results of the final inspection. Ensure compliance with GMP and regulatory standards for recordkeeping.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • BPR: Batch Production Record
  • USP: United States Pharmacopeia

7. Documents

  1. Annexure 1: Packaging Log
  2. Annexure 2: QC Inspection Report
  3. Annexure 3: 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: Packaging Log

Batch ID Packaging Date Number of Capsules Packaged Operator Comments
Batch 018 05/02/2025 100,000 Jane Smith No issues

Annexure 2: QC Inspection Report

Batch ID Inspection Date Defects Identified Corrective Actions Final Outcome
Batch 018 05/02/2025 None None Approved

Annexure 3: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Packaging Machine 701 01/02/2025 John Doe Calibration of filling volume and sealing pressure 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 primary and secondary packaging QA Head
01/02/2025 2.0 Updated packaging and machine setup details Improvement in packaging efficiency and quality control QA Head
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