SOP Guide for Pharma

Capsule: SOP for Conducting Residual Solvent Testing for Capsules – V 2.0

Auditor

Capsule: SOP for Conducting Residual Solvent Testing for Capsules – V 2.0

Standard Operating Procedure for Conducting Residual Solvent Testing for Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/194/2025
Supersedes SOP/CM/194/2022
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 testing residual solvents in capsules to ensure that any solvent residues from the manufacturing process are within acceptable limits to comply with safety and regulatory standards.

2. Scope

This SOP applies to all capsule batches that require residual solvent testing to ensure they meet specified safety and quality standards, particularly concerning solvent residues from gelatin preparation or encapsulation processes.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring the SOP’s adherence to regulatory standards. The QC Supervisor ensures the proper execution of residual solvent testing, and the Production Supervisor ensures the quality of the manufacturing process and timely sample provision.

See also  Capsule: SOP for Sanitizing Capsule Storage Containers - V 2.0

5. Procedure

5.1 Pre-Testing Setup

Before beginning residual solvent testing, ensure the following:

  1. Review Residual Solvent Specifications
    1. Review the residual solvent specifications based on regulatory guidelines (e.g., USP, EP) and the internal quality standards. These should be approved by the QA department before testing.
  2. Prepare Testing Equipment
    1. Ensure that the equipment used for testing residual solvents (e.g., gas chromatograph) is calibrated and in proper working condition.
    2. Verify that all necessary solvents and standards are available for use in the testing procedure.
  3. Prepare Sample Collection
    1. Collect a representative sample of capsules, typically 10-20 capsules per batch, for testing. Ensure that the sample represents the entire batch and is randomly selected.

5.2 Residual Solvent Testing Procedure

Follow these steps to perform the residual solvent test:

  1. Prepare Solvent Extraction
    1. Extract the residual solvents from the capsules using an appropriate solvent, such as water, methanol, or ethanol, based on the solvent’s properties and the expected residuals.
    2. Ensure that the extraction procedure is done under conditions that ensure maximum solvent recovery (e.g., shaking, heating if necessary).
  2. Perform Gas Chromatography (GC) or Other Analytical Testing
    1. Analyze the extracted sample using gas chromatography (GC) or another approved analytical technique (e.g., high-performance liquid chromatography – HPLC) to detect and quantify the residual solvents.
    2. Ensure that the equipment used is calibrated according to standard protocols, and the analysis follows the relevant pharmacopoeial methods (e.g., USP <467> for residual solvents).
  3. Record Results
    1. Record the concentration of each residual solvent detected and calculate the total residual solvent content in the capsules.
    2. Compare the results against the specified limits outlined in the applicable pharmacopoeia and internal quality standards.

5.3 Post-Testing Activities

After completing the residual solvent test, ensure the following:

  1. Review Results
    1. The QA Manager reviews the results to ensure that the residual solvent levels are within the specified limits. If the solvent levels exceed the allowable limits, the batch should be rejected.
  2. Corrective Actions
    1. If any capsules fail the residual solvent test, the root cause should be investigated (e.g., improper drying of gelatin, inadequate encapsulation process). Corrective actions, such as adjusting the process parameters, should be implemented.
  3. Reporting
    1. If required, report the residual solvent levels to the regulatory authorities, especially in cases of high residual levels or non-compliance.
  4. Record Keeping
    1. Ensure that all records related to residual solvent testing, including raw data, test results, and corrective actions, are properly stored and archived according to GMP and regulatory guidelines.

6. Abbreviations

7. Documents

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

8. References

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
GC System 205 01/02/2025 Jane Doe Calibration of solvent detection and quantification system 01/02/2026

Annexure 2: Residual Solvent Testing Log

Capsule ID Test Date Solvent Detected Solvent Level (ppm) Result
Batch 008 02/02/2025 Ethyl acetate 15 ppm Pass

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 008 Excess residual solvent Adjusted drying time and encapsulation 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 residual solvent testing QA Head
01/02/2025 2.0 Updated testing procedure and log format Improvement of testing accuracy and compliance QA Head
See also  Capsule: SOP for Packing Capsules in Aluminum Foil - V 2.0
Exit mobile version