Standard Operating Procedure for Hardness Testing of Tablets

1) Purpose

This SOP outlines the procedures for conducting hardness testing on pharmaceutical tablets to ensure mechanical strength and quality.

2) Scope

This SOP applies to hardness testing of tablets manufactured in the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing hardness testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the hardness testing protocol and ensure all necessary materials and equipment are available (e.g., hardness tester).
2. Verify the calibration and functionality of the hardness tester.

4.2 Sample Collection and Preparation

1. Collect a representative sample of tablets according to sampling procedures.
2. Ensure proper labeling and identification of samples.

4.3 Testing Procedure

1. Place each tablet individually in the hardness tester.
2. Apply pressure to the tablet until it fractures or yields to a predetermined force.
3. Record the hardness value (force required to break the tablet).
4. Repeat the test for the specified number of tablets.

4.4 Acceptance Criteria

1. Ensure that the hardness values of the tested tablets meet the specified range or criteria.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a hardness testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Hardness Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <1217> Tablet Breaking Force, European Pharmacopoeia (Ph. Eur.) 2.9.8 Tablet Friability and Hardness

8) SOP Version

Version 1.0