SOP Guide for Pharma

Capsule: SOP for Process Validation for Controlled-Release Capsule Manufacturing – V 2.0

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Capsule: SOP for Process Validation for Controlled-Release Capsule Manufacturing – V 2.0

Standard Operating Procedure for Process Validation for Controlled-Release Capsule Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/158/2025
Supersedes SOP/CM/158/2022
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 manufacturing process for controlled-release capsules. Controlled-release capsules are designed to release the active pharmaceutical ingredient (API) in a controlled manner over a specified period. This SOP ensures that the controlled-release process is consistent, reproducible, and compliant with regulatory and quality standards.

2. Scope

This SOP applies to the validation of the controlled-release capsule manufacturing process, including equipment, materials, and process parameters involved. It covers all aspects of the process from raw material preparation to final product testing and ensures that the capsules meet the required specifications for controlled release.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the controlled-release capsule manufacturing process is validated according to this SOP. The QA Manager is responsible for reviewing and approving the validation results, ensuring compliance with GMP and regulatory standards.

5. Procedure

5.1 Preparation for Controlled-Release Capsule Validation

Before initiating the validation process, 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 beginning the validation process.
  2. Gather Materials and Equipment
    1. Ensure that all required materials, including the controlled-release formulation, excipients, and capsule shells, are available and meet the quality specifications for the validation process.
    2. Ensure that all manufacturing equipment, such as granulators, capsule filling machines, and coating equipment, are available and ready for use.
  3. Calibrate Equipment
    1. Ensure that all manufacturing equipment is calibrated, including capsule filling machines, coating systems, and dissolution apparatus. Record calibration details in the Equipment Calibration Log (Annexure 1).
See also  Capsule: SOP for Monitoring Capsule Thickness During Drying - V 2.0

5.2 Controlled-Release Capsule Manufacturing Process Validation

Follow these steps to validate the controlled-release capsule manufacturing process:

  1. Pre-Validation Setup
    1. Set up the controlled-release capsule manufacturing system according to the SOP for equipment operation. Ensure that the process parameters, such as granulation speed, coating rates, and drying temperatures, are properly set.
    2. Ensure that environmental conditions, such as temperature and humidity, are controlled and documented in the Environmental Monitoring Log (Annexure 2).
  2. Start the Manufacturing Process
    1. Start the controlled-release capsule manufacturing process by preparing the formulation, followed by granulation, capsule filling, and coating.
    2. Monitor the process to ensure that the capsules are filled with the correct amount of API and coated uniformly. Record all relevant parameters in the Controlled-Release Process Log (Annexure 3).
  3. Monitor Key Process Parameters
    1. Monitor key parameters such as granulation speed, coating thickness, drying temperatures, and fill volume during the validation run.
    2. Ensure that all parameters remain within defined limits, and that the final product meets the required release profile. Document these observations in the Controlled-Release Validation Log (Annexure 4).
  4. Quality Control Testing
    1. Test the capsules for uniformity, controlled-release performance, and dissolution profile. Perform other tests such as hardness and weight uniformity as needed.
    2. Document the test results in the Controlled-Release QC Report (Annexure 5) and ensure they meet 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.
See also  Capsule: SOP for Developing Capsule Fill Formulations - V 2.0

5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

  1. Validation Report
    1. Prepare the Controlled-Release Capsule Manufacturing Validation Report (Annexure 6) summarizing the validation activities, test results, and any corrective actions taken during the process.
  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. Controlled-Release Process Log
    1. Document all parameters related to the controlled-release process, including granulation speed, coating rates, drying temperatures, and fill volumes in the Controlled-Release Process Log (Annexure 3).
  2. Controlled-Release QC Report
    1. Document all quality control test results in the Controlled-Release QC Report (Annexure 5).
  3. Validation Report
    1. Complete the Controlled-Release Capsule Manufacturing Validation Report (Annexure 6) and ensure it is signed and approved by the QA Manager.

6. Abbreviations

7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Environmental Monitoring Log
  3. Annexure 3: Controlled-Release Process Log
  4. Annexure 4: Controlled-Release Validation Log
  5. Annexure 5: Controlled-Release QC Report
  6. Annexure 6: Controlled-Release Validation Report
See also  Capsule: SOP for Cleaning Capsule Filling Machines After Batch Completion - V 2.0

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
Filling Machine 303 01/02/2025 John Doe Filling speed 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: Controlled-Release Process Log

Batch ID Process Date Operator Granulation Speed (RPM) Coating Thickness (mm) Drying Time (hrs) Remarks
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Batch 001 02/02/2025 John Doe 120 RPM 0.8 mm 3 hours Coating uniform, drying process consistent

Annexure 4: Controlled-Release Validation Log

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

Annexure 5: Controlled-Release 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: Controlled-Release 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 process validation of controlled-release capsules QA Head
01/02/2025 2.0 Updated process parameters and enhanced documentation format Optimization and standardization of validation process QA Head
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