and approves the validation plan and results, ensuring that the process is compliant with GMP and regulatory standards.

Engineering Team: Ensures that continuous manufacturing equipment is maintained, calibrated, and operating correctly for validation runs.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the validation of the continuous manufacturing process. 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 Continuous Manufacturing Validation

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

1. Review Validation Plan
   1. Review the validation plan to ensure that it includes objectives, materials, equipment, process parameters, and criteria for acceptance. Ensure that the plan is approved by the QA department before proceeding with validation.
2. Gather Materials and Equipment
   1. Ensure that all necessary materials, including active pharmaceutical ingredients (APIs), excipients, and capsule shells, are available and meet the quality specifications for the validation process.
   2. Ensure that all continuous manufacturing equipment is available and ready for use, including feeders, mixers, capsule fillers, and conveyors.
3. Calibrate Equipment
   1. Ensure that all equipment involved in continuous manufacturing is calibrated, including feeding systems, mixing units, and capsule filling machines. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Continuous Manufacturing Process Validation

Follow these steps to validate the continuous manufacturing process:

1. Pre-Validation Setup
   1. Set up the continuous manufacturing system according to the SOP for equipment operation. Ensure that all process parameters such as feed rates, mixing speeds, and filling volumes are properly set.
   2. Ensure that the environmental conditions, such as temperature, humidity, and air quality, are controlled and documented in the Environmental Monitoring Log (Annexure 2).
2. Start the Continuous Manufacturing Process
   1. Start the continuous manufacturing process by feeding the appropriate amounts of APIs and excipients into the system, ensuring consistent material flow and mixing.
   2. Monitor the process to ensure that the filling machine consistently fills capsules with the appropriate amounts of active ingredients, and record all relevant parameters in the Continuous Manufacturing Process Log (Annexure 3).
3. Monitor Key Process Parameters
   1. Monitor parameters such as material feed rate, capsule fill volume, weight uniformity, and filling speed throughout the validation process.
   2. Record all process parameters and observations in the Continuous Manufacturing Validation Log (Annexure 4) to ensure traceability.
4. Quality Control Testing
   1. Test the capsules produced during the validation run for uniformity, weight, content, and integrity. Perform dissolution and disintegration testing, if applicable.
   2. Document the test results in the Continuous Manufacturing QC Report (Annexure 5) and ensure that they meet the defined specifications.
5. Assess Results and Approve Validation
   1. Review the results from the validation runs and ensure that all process parameters and quality attributes meet the established criteria. If the validation runs are 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 as necessary.

5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

1. Validation Report
   1. Prepare the Continuous Manufacturing Validation Report (Annexure 6) summarizing the validation activities, test results, and corrective actions (if any) taken during the process.
2. Approval of Validation Results
   1. Review and approve the validation report, ensuring 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. Continuous Manufacturing Process Log
   1. Document all parameters related to the continuous manufacturing process, including feed rates, mixing speeds, and fill volumes, in the Continuous Manufacturing Process Log (Annexure 3).
2. Continuous Manufacturing QC Report
   1. Document all quality control test results in the Continuous Manufacturing QC Report (Annexure 5).
3. Continuous Manufacturing Validation Report
   1. Complete the Continuous Manufacturing Validation Report (Annexure 6) and ensure that 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: Continuous Manufacturing Process Log
4. Annexure 4: Continuous Manufacturing Validation Log
5. Annexure 5: Continuous Manufacturing QC Report
6. Annexure 6: Continuous Manufacturing 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	You said: Continue ChatGPT said: html Copy	Next Calibration Due
Filler Machine 101	01/02/2025	John Doe	Pressure 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: Continuous Manufacturing Process Log

Batch ID	Process Date	Operator	Feed Rate (kg/hr)	Mixing Speed (RPM)	Fill Volume (mL)	Remarks
Batch 001	02/02/2025	John Doe	10 kg/hr	120 RPM	1.5 mL	Consistent output

Annexure 4: Continuous Manufacturing Validation Log

Batch ID	Validation Date	Operator	Test Parameters	Results
Batch 001	02/02/2025	Jane Smith	Fill volume, weight uniformity	Pass

Annexure 5: Continuous Manufacturing QC Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	Weight Uniformity	Pass	No issues
Batch 001	02/02/2025	Content Uniformity	Pass	No issues

Annexure 6: Continuous Manufacturing Validation Report

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