Standard Operating Procedure for Tablet Hardness Testing
Purpose
The purpose of this SOP is to provide clear guidelines for the accurate and consistent measurement of tablet hardness in pharmaceutical manufacturing. Tablet hardness testing is a critical quality control parameter that ensures the tablets meet the required specifications and maintain their structural integrity during handling, transportation, and usage.
Scope
This SOP applies to all personnel involved in tablet hardness testing within the pharmaceutical company.
Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Production department is responsible for performing the tablet hardness testing.
Procedure
Preparation
- Ensure that the tablet hardness tester is clean, calibrated, and in proper working condition before starting the testing process.
- Verify that all necessary accessories, such as sample holders and cleaning tools, are available and in good condition.
- Check that the tablet hardness tester is connected to a stable power source and properly grounded.
- Ensure that the tablets to be tested are representative of the batch and have been stored under appropriate conditions.
Testing
- Place the tablet carefully into the sample holder of the hardness tester.
- Adjust the tablet holder and align the tablet surface parallel to the testing probe.
- Start the tablet hardness testing process as per the predetermined testing parameters, including the speed of the testing probe and the dwell time.
- Record the hardness value displayed by the hardness tester for each tablet tested.
- If required, test multiple tablets from the same batch to obtain an average hardness value.
Post-Testing
- Review the hardness test results and compare them with the predefined acceptance criteria specified in the product’s batch record or quality control specifications.
- Document the hardness test results accurately in the appropriate records or data sheets.
- Take appropriate action for any tablets that do not meet the specified hardness requirements, following the company’s standard operating procedures for out-of-specification results.
- Notify the relevant departments if there are any quality issues or deviations found during the hardness testing process.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Tablet Hardness Test Results Log
References
No specific references are applicable for this SOP.
SOP Version
This is version 1.0 of the SOP for Tablet Hardness Testing.