Capsule: SOP for Handling and Storing Gelatin for Capsule Shell Preparation – V 2.0

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Capsule: SOP for Handling and Storing Gelatin for Capsule Shell Preparation – V 2.0

Standard Operating Procedure for Handling and Storing Gelatin for Capsule Shell Preparation

Department Capsule Manufacturing
SOP No. SOP/CM/017/2025
Supersedes SOP/CM/017/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP defines the procedure for handling and storing gelatin used in the preparation of capsule shells to ensure product quality, safety, and compliance with GMP standards.

2. Scope

This SOP applies to the handling, storage, and usage of gelatin for capsule shell preparation in the manufacturing department.

3. Responsibilities

  • Manufacturing Personnel: Responsible for handling gelatin as per the guidelines and ensuring its proper storage and use in capsule production.
  • Quality Control (QC) Team: Ensures that the gelatin used in capsule manufacturing meets quality specifications and verifies the storage conditions are appropriate.
  • Quality Assurance (QA) Team: Oversees compliance with this SOP and ensures proper documentation and traceability of gelatin handling and storage.
  • Warehouse Personnel: Responsible for receiving and storing gelatin in a suitable environment, and ensuring that all storage requirements are met.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring gelatin handling procedures are followed. The QA Manager is responsible for overseeing compliance with storage and quality requirements.

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5. Procedure

5.1 Receiving Gelatin

Follow these steps when receiving gelatin from suppliers:

  1. Check Documentation

    1. Ensure that the gelatin shipment includes the Certificate of Analysis (CoA) and other required documentation, including the batch number and expiry date.
    2. Verify that the received gelatin corresponds with the purchase order in terms of quantity, batch number, and type of gelatin.
  2. Inspect Packaging

    1. Inspect the gelatin packaging for any signs of damage, contamination, or tampering. If damaged, quarantine the material and report the issue.
  3. Labeling

    1. Ensure that the gelatin is properly labeled with the batch number, date of receipt, and storage instructions as per the supplier’s recommendations.

5.2 Storing Gelatin

Ensure proper storage conditions for gelatin to maintain its integrity:

  1. Temperature Control

    1. Store gelatin in a cool, dry environment, ideally between 15°C and 25°C (59°F – 77°F), as recommended by the supplier.
    2. Ensure that gelatin is not exposed to excessive heat or moisture, which could affect its quality and usability.
  2. Humidity Control

    1. Ensure that the storage area has controlled humidity levels to prevent gelatin from becoming brittle or absorbing excess moisture.
    2. Keep gelatin in sealed packaging to protect it from environmental moisture.
  3. Storage Area Security

    1. Store gelatin in a designated, secure area to prevent unauthorized access and contamination from other materials.
    2. Ensure the storage area is clean, well-organized, and free from pests or foreign substances that could affect the gelatin.
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5.3 Handling Gelatin During Capsule Shell Preparation

Ensure that gelatin is handled correctly during capsule shell preparation:

  1. Weighing Gelatin

    1. Before use, weigh the required amount of gelatin according to the formulation and batch record.
    2. Use calibrated weighing equipment to ensure accuracy, and record the quantity weighed in the Material Dispensing Log (Annexure-1).
  2. Mixing Gelatin

    1. Mix gelatin according to the formulation requirements, ensuring that the mixture is uniform and free of clumps.
    2. Follow the approved process parameters for mixing, including time, temperature, and mixing speed.
  3. Temperature Control During Handling

    1. Ensure that the gelatin mixture is maintained at the correct temperature during handling to avoid premature solidification or degradation.
    2. Monitor and document the temperature of the mixture regularly to maintain optimal consistency.

5.4 Documentation and Record-Keeping

Ensure all handling and storage of gelatin are properly documented:

  1. Gelatin Receipt Log

    1. Maintain a Gelatin Receipt Log (Annexure-2) that includes the material name, batch number, supplier details, date of receipt, and quantity received.
  2. Material Dispensing Log

    1. Document all dispensed gelatin quantities in the Material Dispensing Log (Annexure-1), along with the batch number, date, and personnel involved in the dispensing process.
  3. Storage Records

    1. Maintain a record of the storage conditions (e.g., temperature, humidity) to ensure compliance with storage requirements and to track any deviations.

5.5 Disposal of Gelatin Waste

Ensure proper disposal of any gelatin waste:

  1. Segregation of Waste

    1. Separate gelatin waste from other materials and store it in designated waste containers.
    2. Label waste containers as “Gelatin Waste” and ensure they are sealed to prevent contamination.
  2. Disposal Method

    1. Dispose of gelatin waste according to company guidelines and environmental regulations, ensuring that it is either recycled or safely discarded.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • CoA: Certificate of Analysis
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Gelatin Receipt Log (Annexure-2)
  2. Material Dispensing Log (Annexure-1)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Name Batch Number Quantity Dispensed Dispensed By
03/02/2025 Gelatin Type A Batch 12345 500 g John Doe

Annexure-2: Gelatin Receipt Log

Date Material Name Batch Number Supplier Name Quantity Received
02/02/2025 Gelatin Type A Batch 67890 XYZ Gelatin Suppliers 100 kg

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated handling and storage procedures Standardization QA Head
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