Capsule: SOP for Sampling and Testing Gelatin for Capsule Shells – V 2.0

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Capsule: SOP for Sampling and Testing Gelatin for Capsule Shells – V 2.0

Standard Operating Procedure for Sampling and Testing Gelatin for Capsule Shells

Department Capsule Manufacturing
SOP No. SOP/CM/193/2025
Supersedes SOP/CM/193/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP outlines the procedure for sampling and testing gelatin used in the preparation of capsule shells to ensure that it meets the required quality standards for capsule manufacturing.

2. Scope

This SOP applies to all gelatin used in capsule shell production to verify its compliance with quality specifications for gel strength, viscosity, and other relevant physical properties.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for sampling and performing tests on gelatin to ensure it meets the specified quality standards before use in capsule manufacturing.
  • Quality Assurance (QA) Team: Ensures that the gelatin testing process complies with GMP and regulatory standards and approves or rejects gelatin based on test results.
  • Production Team: Provides gelatin samples for testing and ensures proper handling of the gelatin during the manufacturing process.

4. Accountability

The QA Manager is accountable for ensuring that gelatin testing meets all regulatory requirements. The QC Supervisor is responsible for ensuring proper execution of the sampling and testing process. The Production Supervisor is responsible for timely sample provision for testing and proper storage of gelatin.

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5. Procedure

5.1 Pre-Testing Setup

Before starting the sampling and testing of gelatin, ensure the following:

  1. Review Gelatin Specifications

    1. Review the specifications for gelatin quality (e.g., gel strength, viscosity, moisture content) as per regulatory standards (e.g., USP, EP) and the internal quality requirements.
  2. Prepare Sampling Equipment

    1. Ensure that the sampling tools, such as scoops, sample containers, and gloves, are clean and free from contamination.
  3. Prepare Test Equipment

    1. Ensure that all testing equipment, such as viscometers, gel strength testers, and moisture balance, are calibrated and functioning properly.

5.2 Sampling Procedure

Follow these steps for sampling the gelatin:

  1. Take Representative Samples

    1. From the gelatin batch, randomly select multiple samples to ensure they represent the entire batch. The number of samples should meet the minimum sample size requirements outlined in the specifications.
    2. Each sample should be of sufficient quantity to perform all necessary tests (typically 100g-500g depending on the batch size).
  2. Store Samples Properly

    1. Place the samples in clean, labeled containers to avoid contamination and ensure traceability. The samples should be stored in a cool, dry place until testing is completed.

5.3 Testing Procedure

Follow these steps to test the gelatin samples:

  1. Viscosity Testing

    1. Using a viscometer, measure the viscosity of the gelatin solution to determine the consistency and flow properties. Record the viscosity and compare it with the specified limits.
  2. Gel Strength Testing

    1. Using a gel strength tester, measure the gel strength of the gelatin. Gel strength should meet the specified values to ensure proper shell formation and stability.
  3. Moisture Content Testing

    1. Test the moisture content of the gelatin using a moisture balance or oven method. The moisture content should fall within the specified range to prevent issues during encapsulation.
  4. Other Quality Tests

    1. If necessary, perform additional tests, such as ash content, pH level, or microbial contamination, based on the specific gelatin used.
  5. Record Results

    1. Document the results of all tests and compare them against the acceptance criteria. If the gelatin passes all tests, it is approved for use in capsule production.
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5.4 Post-Testing Activities

After completing the tests, ensure the following:

  1. Review Results

    1. The QA Manager reviews the testing results to determine if the gelatin meets the required specifications. If any results do not meet the criteria, the gelatin should be rejected and the supplier notified.
  2. Corrective Actions

    1. If the gelatin fails to meet the required specifications, investigate the root cause, such as issues in the gelatin preparation, supplier quality, or storage conditions. Implement corrective actions accordingly.
  3. Feedback and Training

    1. Provide feedback to the suppliers and internal teams about the testing failures and implement any necessary training to prevent recurrence of issues.
  4. Record Keeping

    1. Ensure that all records related to gelatin testing, including raw data, test results, and corrective actions, are properly stored and archived for future reference and regulatory compliance.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • API: Active Pharmaceutical Ingredient
  • USP: United States Pharmacopeia
  • EP: European Pharmacopeia
  • RSD: Relative Standard Deviation

7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Gelatin Testing Log
  3. Annexure 3: Corrective Action Report

8. References

  • USP <401> – Gelatin
  • European Pharmacopoeia 2.9.1 – Gelatin
  • 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: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Viscometer 112 01/02/2025 John Doe Calibration of viscosity measurements 01/02/2026

Annexure 2: Gelatin Testing Log

Sample ID Test Date Viscosity (cP) Gel Strength (g) Moisture Content (%) Result
Batch 007 02/02/2025 200 80 12% Pass

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 007 Excess moisture content Adjusted gelatin mixing parameters Production Supervisor 03/02/2025

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 sampling and testing gelatin QA Head
01/02/2025 2.0 Updated testing procedures and logs Improvement of testing accuracy and compliance QA Head
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