Reviews and approves the validation plan and results to ensure compliance with GMP and regulatory requirements.

Engineering Team: Responsible for maintaining and calibrating the capsule filling equipment used in the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the validation process is carried out according to this SOP. The QA Manager is responsible for reviewing and approving the validation plan and results.

5. Procedure

5.1 Preparation for Process Validation

Before starting the process validation, ensure the following preparations are made:

1. Review Validation Plan
   1. Review the validation plan and ensure that all requirements for the validation study are met. The plan should include details such as materials, equipment, personnel, and validation criteria.
2. Gather Materials
   1. Ensure that all materials required for the validation study, including capsule shells, fillers, and excipients, are available and of the required quality.
   2. Verify that materials are approved for use in capsule production and meet specifications for the validation study.
3. Calibrate Equipment
   1. Ensure that the capsule filling equipment is properly calibrated and functioning according to specifications. Record calibration details in the Equipment Maintenance Log (Annexure-1).

5.2 Process Validation Procedure

Follow these steps to carry out the process validation:

1. Perform Pre-Validation Setup
   1. Set up the capsule filling machine according to the standard operating procedures, ensuring all components are in place and functional.
   2. Verify the cleanliness and suitability of the environment in which the validation will take place (e.g., controlled temperature and humidity conditions).
2. Conduct Validation Batches
   1. Perform the filling process using the specified materials and machine settings. Record all relevant parameters, including capsule weight, fill volume, and other critical process variables.
   2. Use a minimum of three batches for validation to assess the consistency and reproducibility of the process. Each batch should be run under normal production conditions.
3. Monitor Process Parameters
   1. Monitor the key process parameters (e.g., fill weight, capsule integrity) during the validation runs. Ensure that these parameters stay within the acceptable limits established by the validation plan.
   2. Record data at regular intervals throughout the validation process to ensure consistent results.
4. Perform Quality Control Testing
   1. After each batch, perform quality control tests on the capsules, including weight uniformity, content uniformity, and integrity testing, to ensure they meet the specifications.
   2. Test capsules for dissolution, disintegration, and other relevant tests to verify product performance.
5. Assess Results
   1. Review the results of the validation runs and compare them with the acceptance criteria. Determine whether the process is consistently producing capsules that meet the specified quality standards.
   2. If any deviations or out-of-specification results occur, investigate the root cause and take corrective actions. Re-run the validation if necessary.

5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

1. Complete Validation Report
   1. Document all results, including the data collected during the validation batches, testing results, and any corrective actions taken in the Process Validation Report (Annexure-2).
2. Approval of Validation Results
   1. Have the validation results reviewed and approved by the QA Manager. Ensure that all necessary signatures and approvals are obtained before the process is considered validated and approved for routine use.

5.4 Documentation

Ensure proper documentation of the process validation for traceability:

1. Process Validation Report
   1. Complete the Process Validation Report, which includes a summary of the validation procedure, equipment used, batch details, test results, and any corrective actions.
2. Validation Logs
   1. Document all process validation activities in the Process Validation Log (Annexure-3) to ensure traceability and compliance.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. Process Validation Report (Annexure-2)
2. Process Validation Log (Annexure-3)
3. Cleaning Log (Annexure-1)

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-2: Process Validation Report

Batch ID	Validation Date	Operator	Test Results	Corrective Actions	Approval Status
Batch 001	03/02/2025	John Doe	Pass	No corrective action needed	Approved for use

Annexure-3: Process Validation Log

Batch ID	Test Date	Operator	Test Parameters	Results
Batch 001	03/02/2025	Jane Smith	Weight, Fill Volume	Within limits

Annexure-1: Equipment Maintenance Log

Machine ID	Maintenance Date	Maintenance Details	Operator	Next Maintenance Due
Machine 001	02/02/2025	Routine cleaning and calibration	Jane Smith	02/02/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version	New SOP Creation	QA Head
01/02/2025	2.0	Updated process validation procedure	Improved process controls	QA Head