the hardness testing is conducted according to GMP and regulatory requirements. The QC Supervisor ensures proper execution of the testing procedure, and the Production Supervisor ensures the proper handling and quality control of the capsule shells during manufacturing.

5. Procedure

5.1 Pre-Testing Setup

Before performing hardness testing on capsule shells, ensure the following:

1. Review Hardness Specifications
   1. Review the hardness specifications for the capsule shells, which should meet the required minimum and maximum values for the specific capsule type being produced.
2. Prepare Testing Equipment
   1. Ensure that the hardness testing equipment (e.g., tablet hardness testers or force gauges) is calibrated and ready for use. The equipment should be capable of measuring the force required to break or crush the capsule shell.
3. Sample Collection
   1. Collect a representative sample of capsule shells from the batch. Typically, 6-10 capsules are selected for testing, depending on batch size and regulatory guidelines.

5.2 Hardness Testing Procedure

Follow these steps to test the hardness of the capsule shells:

1. Place Capsule in Testing Device
   1. Place each capsule in the hardness tester, ensuring it is properly aligned in the device to prevent any mechanical errors during testing.
2. Measure Hardness
   1. Apply force to the capsule using the tester and record the maximum force required to break or crush the capsule shell. This value should be in the specified range for the product type (e.g., 4-12 N for standard gelatin capsules).
3. Repeat Testing
   1. Perform the hardness test on multiple capsules from the sample to ensure that the batch consistency meets the required standards. Record the results for each capsule tested.
4. Calculate Average Hardness
   1. Calculate the average hardness of the tested capsules to assess the overall consistency of the batch. This should fall within the acceptable limits established by the product specifications.

5.3 Post-Testing Activities

After completing the hardness test, ensure the following:

1. Review Results
   1. The QA Manager reviews the hardness test results to ensure that the capsules meet the required hardness specifications. If any capsules fall outside the acceptable range, further investigation is required.
2. Corrective Actions
   1. If any capsules fail to meet the required hardness specifications, the root cause should be investigated (e.g., improper capsule drying, incorrect formulation parameters) and corrective actions should be implemented.
3. Report and Release
   1. Provide the test results to the regulatory authorities if required, especially in cases where deviations or failures have been observed.
   2. If the capsules meet the hardness specifications, release the batch for further processing, such as filling and packaging.
4. Record Keeping
   1. Ensure that all test results, observations, and corrective actions are documented and stored in compliance with GMP and regulatory guidelines. These records should be readily accessible for future reference or audits.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• HPLC: High-Performance Liquid Chromatography
• USP: United States Pharmacopeia
• EP: European Pharmacopeia

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Hardness Testing Log
3. Annexure 3: Corrective Action Report

8. References

• USP <701> – Disintegration of Tablets and Capsules
• European Pharmacopoeia 2.9.1 – Dissolution Testing
• 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
Hardness Tester 408	01/02/2025	John Doe	Calibration of force measurement system	01/02/2026

Annexure 2: Hardness Testing Log

Batch ID	Test Date	Capsule ID	Hardness (N)	Result
Batch 011	02/02/2025	Capsule A	8.5	Pass

Annexure 3: Corrective Action Report

Batch ID	Deviation	Corrective Action	Responsible Person	Completion Date
Batch 011	Hardness outside range	Adjusted capsule drying time	Production Supervisor	03/02/2025

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 hardness testing	QA Head
01/02/2025	2.0	Updated testing procedure and log format	Improvement of testing accuracy and compliance	QA Head