reviewing and approving the results to ensure consistency and reliability.

5. Procedure

5.1 Test Preparation

1. Review the analytical method to be tested for intermediate precision (e.g., HPLC, UV-Vis, or GC).
2. Obtain a representative sample of the tablet formulation for testing.
3. Prepare the sample and solutions as per the analytical method’s requirements.
4. Ensure that the laboratory equipment and instruments (e.g., HPLC system, UV-Vis spectrophotometer) are calibrated and functioning properly before starting the tests.

5.2 Selection of Operators

1. Choose at least two qualified laboratory personnel who will perform the testing independently to ensure operator variability.
2. Ensure that both operators are trained in the same method and use the same procedure for testing, but perform the tests at different times and possibly under different conditions (e.g., different equipment setups, different shifts).

5.3 Intermediate Precision Testing Procedure

1. Perform the analysis for the tablet sample using the selected analytical method (e.g., HPLC, UV-Vis, or GC) according to the method’s standard operating procedure.
2. Have each operator conduct the analysis at separate times to account for variability in the method. Ensure that the same set of samples and conditions is used for each test.
3. Each operator should perform multiple replicate tests (usually 6–10) per condition to assess precision.
4. Record all relevant data, including sample preparation, instrument settings, and results of the analysis.

5.4 Data Analysis

1. Calculate the mean, standard deviation, and coefficient of variation (CV) for the results obtained by each operator.
2. Compare the variability between the two operators. The data should be evaluated using the following criteria:
   • The CV for each operator should not exceed a predefined limit (usually 2%–5%, depending on the method and specifications).
   • The difference in mean results between operators should be minimal, indicating consistency.
3. If the CV for either operator exceeds the predefined limit, further investigation should be carried out to determine the cause of the inconsistency.

5.5 Acceptance Criteria

1. The analytical method is considered to have passed the intermediate precision test if the variation between the results from both operators is within the acceptable limits (e.g., CV <5%).
2. If the test results do not meet the acceptance criteria, investigate the reasons for the failure and perform corrective actions (e.g., retraining of operators, equipment maintenance, or recalibration).

5.6 Documentation and Record-Keeping

1. Document all intermediate precision testing results, including the data from each operator, statistical calculations, and any deviations from the expected results in the batch record (Annexure-2).
2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
3. Maintain raw data, including chromatograms, spectra, and test reports, for regulatory compliance and future reference.

5.7 Post-Test Actions

1. Clean the laboratory equipment and instruments after each use to avoid cross-contamination between tests.
2. Dispose of any used samples, reagents, or solvents according to the company’s waste disposal procedures.
3. Ensure that the analytical instruments are regularly calibrated and maintained according to the manufacturer’s instructions and company SOPs.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CV: Coefficient of Variation
• HPLC: High-Performance Liquid Chromatography
• UV-Vis: Ultraviolet-Visible Spectroscopy
• GC: Gas Chromatography

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <621> – Chromatography
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Specifications for Chromatography and Method Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	High variability in operator results	Retrained operators and recalibrated equipment	John Doe

Annexure-2: Batch Record

Batch Number	Operator 1 Result	Operator 2 Result	Mean Result	CV (%)	Pass/Fail
Batch 001	98.0%	97.8%	97.9%	0.2%	Pass

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Data Analysis Method	Improved method consistency	QA Head