Capsule: SOP for Process Validation of Enteric Coating for Capsules – V 2.0

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Capsule: SOP for Process Validation of Enteric Coating for Capsules – V 2.0

Standard Operating Procedure for Process Validation of Enteric Coating for Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/157/2025
Supersedes SOP/CM/157/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the process for validating the enteric coating process for capsules. The enteric coating is applied to capsules to prevent premature disintegration in the stomach and to ensure drug release in the intestine. This SOP ensures the coating process is consistent, reproducible, and compliant with regulatory and quality standards.

2. Scope

This SOP applies to the validation of the enteric coating process for capsules in the manufacturing environment. It includes validation of equipment, process parameters, materials used in the coating process, and personnel involved. This SOP is designed to ensure the enteric coating is applied correctly and meets the required specifications.

3. Responsibilities

  • Production Operators: Responsible for operating the enteric coating equipment and ensuring that all process parameters are maintained during the validation process.
  • Quality Control (QC) Team: Performs testing on the coated capsules to ensure they meet the quality specifications for coating integrity, disintegration, and release.
  • Quality Assurance (QA) Team: Reviews and approves the validation plan, process parameters, and results, ensuring that the process complies with GMP and regulatory standards.
  • Engineering Team: Ensures that the enteric coating equipment is properly calibrated, maintained, and functioning during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the enteric coating process is validated according to this SOP. The QA Manager is responsible for reviewing and approving the validation results and ensuring compliance with GMP and regulatory standards.

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5. Procedure

5.1 Preparation for Enteric Coating Validation

Before initiating the validation, ensure the following preparations are made:

  1. Review Validation Plan

    1. Review the validation plan, which should include objectives, equipment, materials, process parameters, and acceptance criteria. Ensure that the plan is approved by the QA department before starting the validation activities.
  2. Gather Materials and Equipment

    1. Ensure that all necessary materials, including enteric coating solutions, capsule shells, and any excipients, are available and meet the quality specifications for the validation process.
    2. Ensure that the enteric coating equipment, including spray coating systems, curing ovens, and drying equipment, are available and ready for use.
  3. Calibrate Equipment

    1. Ensure that all enteric coating equipment is calibrated, including spray nozzles, temperature control systems, and drying systems. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Enteric Coating Process Validation

Follow these steps to validate the enteric coating process:

  1. Pre-Validation Setup

    1. Set up the enteric coating system according to the SOP for coating operations. Ensure that the process parameters such as spray rate, coating solution temperature, and drying temperature are properly set.
    2. Ensure that the environmental conditions, such as temperature and humidity, are controlled and documented in the Environmental Monitoring Log (Annexure 2).
  2. Start the Coating Process

    1. Start the enteric coating process by feeding the capsules into the coating system and applying the coating solution using the pre-determined spray rate and temperature conditions.
    2. Monitor the process to ensure uniform coating and proper curing, and record all relevant parameters in the Enteric Coating Process Log (Annexure 3).
  3. Monitor Process Parameters

    1. Monitor key parameters such as spray rate, solution temperature, drying time, and coating thickness throughout the validation process.
    2. Ensure that the parameters are within the defined limits and that the capsule coating meets the specified uniformity criteria. Record observations and data in the Enteric Coating Validation Log (Annexure 4).
  4. Quality Control Testing

    1. After coating, test the capsules for coating integrity, disintegration time, and drug release. Perform additional tests such as dissolution and hardness testing as required.
    2. Document the test results in the Enteric Coating QC Report (Annexure 5) and ensure that the results meet the acceptance criteria.
  5. Assess Results and Approve Validation

    1. Review the results from the validation run and assess whether all process parameters and product attributes meet the established criteria. If successful, approve the process for routine production.
    2. If any deviations or non-conformances are identified, investigate the cause and take corrective actions. Revalidate the process if necessary.
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5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

  1. Coating Process Validation Report

    1. Prepare the Enteric Coating Process Validation Report (Annexure 6) summarizing the validation activities, results, and any corrective actions taken.
  2. Approval of Validation Results

    1. Review and approve the validation report to ensure that all data meets the validation criteria. The report should be signed and approved by the QA Manager.

5.4 Documentation

Ensure proper documentation of the process for traceability and regulatory compliance:

  1. Enteric Coating Process Log

    1. Document all process parameters, including spray rate, solution temperature, drying time, and coating thickness, in the Enteric Coating Process Log (Annexure 3).
  2. Enteric Coating QC Report

    1. Document all quality control test results in the Enteric Coating QC Report (Annexure 5).
  3. Coating Process Validation Report

    1. Complete the Enteric Coating Process Validation Report (Annexure 6) and ensure it is signed and approved by the QA Manager.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • API: Active Pharmaceutical Ingredient
  • RPM: Revolutions Per Minute

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7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Environmental Monitoring Log
  3. Annexure 3: Enteric Coating Process Log
  4. Annexure 4: Enteric Coating Validation Log
  5. Annexure 5: Enteric Coating QC Report
  6. Annexure 6: Coating Process Validation Report

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • 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
Coating Machine 202 01/02/2025 John Doe Spray nozzle and temperature calibration 01/02/2026

Annexure 2: Environmental Monitoring Log

Date Temperature (°C) Humidity (%) Operator Remarks
02/02/2025 22°C 50% Jane Smith No issues

Annexure 3: Enteric Coating Process Log

Batch ID Process Date Operator Spray Rate (L/hr) Coating Solution Temp (°C) Drying Temp (°C) Remarks
Batch 001 02/02/2025 John Doe 5 L/hr 25°C 50°C Coating uniform

Annexure 4: Enteric Coating Validation Log

Batch ID Validation Date Operator Test Parameters Results
Batch 001 02/02/2025 Jane Smith Coating uniformity, disintegration time Pass

Annexure 5: Enteric Coating QC Report

Batch ID Test Date Test Type Results Remarks
Batch 001 02/02/2025 Coating Integrity Pass No issues
Batch 001 02/02/2025 Disintegration Time Pass Meets specification

Annexure 6: Coating Process Validation Report

Batch ID Validation Date Operator Test Parameters Results Action Taken
Batch 001 02/02/2025 John Doe Coating uniformity, dissolution Pass Approved for routine production

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 enteric coating validation process QA Head
01/02/2025 2.0 Updated process parameters and documentation format Process optimization and standardization QA Head
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