standards. The report documents the results of the method validation study and forms the basis for regulatory submission and routine use.

2. Scope

This SOP applies to all analytical methods validated within the Analytical Method Development (AMD) department, including assay, dissolution, content uniformity, impurity, and cleaning validation methods.

3. Responsibilities

• Analytical Scientist: Compiles the validation report including raw data summaries, results, and conclusions.
• Group Leader: Reviews report for technical accuracy and completeness.
• QA Reviewer: Verifies report content and ensures compliance with regulatory and internal standards.
• Department Head: Approves the final report and authorizes its archival and distribution.

4. Accountability

The Head of Analytical Method Development is accountable for the accuracy, integrity, and timely approval of all validation reports generated by the department.

5. Procedure

5.1 Report Structure

1. Prepare the report using the following structure:
   • Title page with method name, product name, validation number, and dates
   • Table of contents
   • Objective and scope
   • Validation protocol reference
   • Materials and instrumentation
   • Experimental details for each parameter
   • Results and discussion
   • Conclusion and recommendation
   • Annexures (raw data, chromatograms, tables)

5.2 Compilation of Results

1. Include raw data summaries and statistical evaluations for:
   • Specificity
   • Linearity
   • Accuracy
   • Precision (repeatability and intermediate precision)
   • LOD and LOQ
   • Robustness
   • System suitability
2. Use clearly labeled tables and graphs (where applicable).
3. Reference annexure numbers for chromatograms and calculations.

5.3 Review and Approval

1. Group Leader checks consistency with validation protocol and verifies accuracy of results.
2. QA reviews:
   • Compliance with regulatory guidelines (ICH, WHO, GMP)
   • Inclusion of all mandatory sections
   • Raw data cross-referencing
3. Once reviewed, Department Head provides final approval.
4. Store a signed copy in the validation archive and distribute soft copies to stakeholders.

5.4 Deviation Handling

1. Document and investigate any deviations observed during validation.
2. Record deviation references in the report body and summarize in Annexure-4.

6. Abbreviations

• SOP: Standard Operating Procedure
• LOD: Limit of Detection
• LOQ: Limit of Quantification
• QA: Quality Assurance
• RSD: Relative Standard Deviation

7. Documents

1. Validation Report Template – Annexure-1
2. Statistical Data Tables – Annexure-2
3. Chromatogram Index – Annexure-3
4. Deviation Summary – Annexure-4

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• GMP Guidelines – Schedule M
• WHO TRS 996

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Ritika Sharma	Anand Iyer	Sunita Reddy
Designation	Scientific Writer	QA Reviewer	Department Head
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Validation Report Template

Standard template available under document code: AMD/VAL/REP/TEMP/01

Annexure-2: Statistical Data Tables

Parameter	Mean	SD	RSD (%)	Status
Precision	99.1	0.6	0.61%	Pass

Annexure-3: Chromatogram Index

All chromatograms are filed under QA/AMD/CHROM/209/2025 and digitally archived.

Annexure-4: Deviation Summary

Deviation ID	Description	Impact	Corrective Action
AMD/DEV/005	Precision data reprocessed due to software issue	Minor	Software revalidated, data integrity verified

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Updated structure and annexure formats	Annual SOP Review	Sunita Reddy
08/03/2022	1.0	Initial Issue	New SOP	QA Head