process parameters, and results, ensuring that the process complies with GMP and regulatory standards.

Engineering Team: Ensures that manufacturing equipment is properly calibrated, maintained, and functioning during validation runs.

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).

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.

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

• 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

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

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
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 You said: Continue ChatGPT said: html Copy
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