validated within the Analytical Method Development (AMD) department, including assay, dissolution, impurity profiling, and content uniformity tests.

3. Responsibilities

• Analytical Scientist: Designs the precision study and interprets data.
• Validation Analyst: Executes replicate sample analysis across same-day and inter-day conditions.
• QA Officer: Verifies compliance and reviews final precision report.
• Head – AMD: Authorizes the precision evaluation and report for regulatory use.

4. Accountability

The Head of AMD is accountable for ensuring that the precision and repeatability assessments meet acceptable statistical and regulatory criteria.

5. Procedure

5.1 Repeatability Assessment

1. Prepare six individual test solutions from the same homogeneous sample batch.
2. Analyze each solution under identical conditions using the validated method.
3. Record peak area, retention time, and concentration in Annexure-1: Repeatability Data Sheet.
4. Calculate:
   • Mean
   • Standard Deviation (SD)
   • Relative Standard Deviation (%RSD)

5.2 Intermediate Precision (Ruggedness)

1. Repeat analysis using:
   • Different analysts
   • Different instruments
   • Different days (minimum 2)
2. Use same sample preparation protocol for each analyst.
3. Record all observations in Annexure-2: Intermediate Precision Summary.
4. Compare results across sets using statistical tools such as ANOVA.

5.3 Acceptance Criteria

1. Repeatability: %RSD should be ≤ 2.0% for assay methods.
2. Intermediate Precision: %RSD across all variables should be ≤ 3.0%.
3. Results must be consistent and within specification limits.

5.4 Reporting

1. Prepare a consolidated report summarizing:
   • Repeatability results
   • Intermediate precision results
   • Acceptance status
2. Attach chromatograms and instrument printouts.
3. Summarize results in Annexure-3: Precision Validation Summary Report.

6. Abbreviations

• RSD: Relative Standard Deviation
• SD: Standard Deviation
• SOP: Standard Operating Procedure
• AMD: Analytical Method Development
• ANOVA: Analysis of Variance
• ICH: International Council for Harmonisation

7. Documents

1. Repeatability Data Sheet – Annexure-1
2. Intermediate Precision Summary – Annexure-2
3. Precision Validation Summary Report – Annexure-3

8. References

• ICH Q2(R2) – Validation of Analytical Procedures
• FDA Guidance – Analytical Procedures and Methods Validation
• Internal AMD Quality Manual

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Repeatability Data Sheet

Sample No.	Peak Area	Calculated Result (%)
1	543210	99.2%
2	541890	98.9%
3	545000	99.5%
4	542100	99.0%
5	543800	99.3%
6	544200	99.4%

Annexure-2: Intermediate Precision Summary

Day	Analyst	Instrument	Average Result (%)
Day 1	Rajesh Kumar	HPLC-01	99.1%
Day 2	Sunita Reddy	HPLC-02	98.8%

Annexure-3: Precision Validation Summary Report

Parameter	Result	Acceptance Criteria	Status
Repeatability (%RSD)	0.45%	≤ 2.0%	Pass
Intermediate Precision (%RSD)	0.72%	≤ 3.0%	Pass

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added intermediate precision criteria and annexures for statistical reporting	Regulatory alignment