Capsule: SOP for Identification Testing of Capsule Fill Materials – V 2.0

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Capsule: SOP for Identification Testing of Capsule Fill Materials – V 2.0

Standard Operating Procedure for Identification Testing of Capsule Fill Materials

Department Capsule Manufacturing
SOP No. SOP/CM/195/2025
Supersedes SOP/CM/195/2022
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 performing identification testing of capsule fill materials to ensure that the correct substances are used in the formulation and that they meet the necessary regulatory and quality standards.

2. Scope

This SOP applies to all fill materials used in capsule production, including active pharmaceutical ingredients (APIs) and excipients, to verify that they meet identity and purity standards before use in manufacturing.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for performing identification testing on all capsule fill materials and recording the test results in compliance with regulatory guidelines.
  • Quality Assurance (QA) Team: Ensures that the testing procedures are followed correctly and that the results meet established specifications before approving materials for use in production.
  • Procurement Team: Responsible for ensuring that fill materials are sourced from approved vendors and meet the required quality standards before they are supplied to production.

4. Accountability

The QA Manager is responsible for ensuring that the identification testing is conducted according to GMP and regulatory requirements. The QC Supervisor ensures that the testing process is executed properly, and the Production Supervisor ensures the correct handling and use of fill materials during manufacturing.

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5. Procedure

5.1 Pre-Testing Setup

Before performing identification testing on capsule fill materials, ensure the following:

  1. Review Material Specifications

    1. Review the material specifications for all capsule fill materials (APIs and excipients), ensuring they meet the required identity, purity, and quality standards as per regulatory guidelines (e.g., USP, EP).
  2. Prepare Testing Equipment

    1. Ensure that all equipment used for identification testing, such as UV spectrophotometers, HPLC, or FTIR spectrometers, is calibrated and ready for use.
    2. Prepare reagents and standards required for the identification tests, including solvent systems, reference standards, and chemical reagents, if applicable.
  3. Prepare Sample Collection

    1. Collect a representative sample of the capsule fill material from the batch. Ensure that the sample is properly labeled and of sufficient size for testing.

5.2 Identification Testing Procedure

Follow these steps to perform the identification testing:

  1. Visual Inspection

    1. Perform a visual inspection of the fill material. Ensure that the material’s appearance, color, and consistency match the specifications and known characteristics for that substance.
  2. Preliminary Identification

    1. For excipients or APIs with known characteristics, perform simple preliminary tests, such as checking solubility in a specified solvent or performing a simple reaction (e.g., acid/base reaction) to confirm the substance’s identity.
  3. Instrumental Testing

    1. For more complex or critical ingredients, use appropriate instrumental methods such as UV-VIS spectrophotometry, HPLC, or FTIR to perform the identification testing. Compare the results with the reference standards to confirm the material’s identity.
  4. Comparison with Standards

    1. For each test performed, compare the sample’s result with the known standard or reference material to confirm that the material meets the identity criteria.
  5. Record Results

    1. Document the results of each test, including the type of test performed, the results obtained, and any deviations from the expected results. Record all results in the testing log for future reference.
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5.3 Post-Testing Activities

After completing the identification tests, ensure the following:

  1. Review Results

    1. The QA Manager reviews the results to ensure the materials meet the required identification criteria. If the material fails any test, it must be rejected and not used in production.
  2. Corrective Actions

    1. If the material fails the identity test, the cause should be investigated (e.g., wrong material, contamination). The material must be sent back to the supplier if necessary, and corrective actions should be implemented.
  3. Approval and Release

    1. If the material passes the tests, the QA team approves the batch for use in production, and the material is released for further processing.
  4. Record Keeping

    1. Ensure that all test records, including raw data, test results, and corrective actions, are stored and archived in accordance with GMP and regulatory guidelines.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • HPLC: High-Performance Liquid Chromatography
  • FTIR: Fourier Transform Infrared Spectroscopy
  • USP: United States Pharmacopeia
  • EP: European Pharmacopeia
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7. Documents

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

8. References

  • USP <467> – Residual Solvents
  • European Pharmacopoeia 2.4.24 – Residual Solvents
  • 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
HPLC System 207 01/02/2025 Jane Doe Calibration of solvent delivery and detector system 01/02/2026

Annexure 2: Identification Testing Log

Material ID Test Date Test Method Result Acceptance Criteria
Batch 009 02/02/2025 HPLC Pass Meets all specifications

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 009 Incorrect API identification Returned to supplier for clarification Procurement 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 identification testing QA Head
01/02/2025 2.0 Updated testing procedure and log format Improvement of testing accuracy and compliance QA Head
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