Standard Operating Procedure for Validation of Capsule Size Sorting Machines

Department	Capsule Manufacturing
SOP No.	SOP/CM/170/2025
Supersedes	SOP/CM/170/2022
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 validation process for capsule size sorting machines used in the capsule manufacturing process. The validation ensures that the machine can accurately sort capsules according to size, ensuring uniformity and consistency in the final product. This SOP ensures the equipment is operating within the specified limits and complies with GMP and regulatory standards.

2. Scope

This SOP applies to the validation of all capsule size sorting machines used in the production of capsules. It includes the validation process, including equipment calibration, functional tests, and performance checks to confirm that the machine performs according to its design specifications.

3. Responsibilities

• Engineering Team: Responsible for installing, configuring, and setting up the capsule size sorting machine, and performing the initial validation tests to ensure proper functionality.
• Quality Control (QC) Team: Responsible for performing the functional tests, verifying the performance of the machine, and documenting the results of the validation process.
• Quality Assurance (QA) Team: Reviews and approves the validation documentation to ensure compliance with GMP and regulatory standards.
• Production Team: Ensures that the capsule size sorting machine is fully integrated into the production process and is ready for regular use after successful validation.

4. Accountability

The Engineering Supervisor is responsible for ensuring that the capsule size sorting machine is correctly installed, calibrated, and set up for validation. The QA Manager is responsible for reviewing and approving the validation documentation to ensure compliance with GMP and regulatory standards. The Production Supervisor ensures that the machine is fully functional and integrated into production after successful validation.

5. Procedure

5.1 Pre-Validation Setup

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

1. Review Validation Plan
   1. Review the validation plan to ensure it includes all necessary tests, equipment specifications, and acceptance criteria. The plan should be approved by the QA department before initiating validation.
2. Prepare the Equipment
   1. Ensure that the capsule size sorting machine is installed and connected to the production line, with all required utilities (electricity, compressed air) properly set up.
   2. Verify that the machine is in a clean and well-maintained state and free from any obstructions that may affect its functionality.
3. Calibrate the Equipment
   1. Calibrate the machine according to the manufacturer’s instructions to ensure it is functioning within the specified limits for capsule size sorting.
   2. Record the calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Performance Qualification (PQ) Testing

Follow these steps to perform the operational qualification of the capsule size sorting machine:

1. Test Sorting Accuracy
   1. Test the accuracy of the capsule size sorting machine by using a known sample of capsules with different sizes. Verify that the machine accurately sorts the capsules according to the specified size criteria.
2. Verify Sorting Speed and Throughput
   1. Test the sorting speed and throughput of the machine. Ensure that the machine can handle the required volume of capsules within the specified time limits.
3. Test Performance Under Production Conditions
   1. Run the capsule size sorting machine under normal production conditions to verify that it can perform accurately over extended periods and with varying capsule sizes. Document the results in the Validation Log (Annexure 2).
4. Verify Alarm and Rejection Systems
   1. Test the machine’s alarm system to ensure that it activates when the capsule sorting process is disrupted or when incorrect sizes are detected. Ensure the system properly rejects out-of-specification capsules.
5. Document PQ Results
   1. Document the results of all performance tests. If any deviations occur, investigate the cause and take corrective actions. Re-test the machine until it meets all the acceptance criteria.

5.3 Post-Qualification Activities

After successful completion of the PQ process, ensure the following tasks are completed:

1. Operator Training
   1. Provide training for operators on the proper use of the capsule size sorting machine, including how to handle capsules of different sizes, interpret sorting data, and troubleshoot any issues that may arise.
2. Sign-Off and Approval
   1. Ensure that the PQ process is successfully completed, and the machine is signed off for use in production by the QA Manager. The PQ Report should be approved and filed for record-keeping.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• PQ: Performance Qualification
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Performance Qualification Log
3. Annexure 3: Performance Qualification Report

8. References

• FDA Guidelines on Equipment Performance Qualification
• Good Manufacturing Practice (GMP) Guidelines
• USP <1058> – Equipment Qualification

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
Sorting Machine 506	01/02/2025	John Doe	Calibration of sorting speed and size parameters	01/02/2026

Annexure 2: Performance Qualification Log

Batch ID	PQ Date	Operator	Test Type	Results
Batch 001	02/02/2025	Jane Smith	Size Sorting Test	Pass

Annexure 3: Performance Qualification Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	Functional Test	Pass	Machine successfully sorted capsules to specification

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 validation of capsule size sorting machines	QA Head
01/02/2025	2.0	Updated sorting parameters and added new machine functionality tests	Improvement of validation tests and inclusion of updated criteria	QA Head