applies to all analytical method development (AMD) personnel and QA reviewers involved in the evaluation of analytical data generated during development, validation, or transfer studies.

3. Responsibilities

• Analyst: Ensures that all data entries, observations, and calculations are complete, legible, and initialed.
• AMD Reviewer: Conducts comprehensive review of raw data, calculations, chromatograms, and logbook entries.
• QA Representative: Verifies compliance with data integrity principles, protocol requirements, and SOPs.

4. Accountability

The AMD Department Head is accountable for implementing this SOP and ensuring that no analytical report is finalized without documented evidence of prior data review and verification.

5. Procedure

5.1 Preparation for Documentation Review

1. Ensure that the analytical study is complete and all associated raw data is compiled.
2. Check inclusion of:
   • Sample preparation records
   • Instrument usage logs
   • System suitability data
   • Chromatograms with peak annotations
   • Calibration curves, calculations, and worksheets

5.2 Data Integrity and Compliance Verification

1. Verify ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
2. Cross-check calculations using approved spreadsheet or manual formulas, as applicable.
3. Confirm that any corrections are GMP-compliant and justified.

5.3 Checklist-Based Review

1. Use Annexure-1: Pre-Report Review Checklist to confirm the presence and review of each required document and entry.
2. Note any missing or inconsistent data and return to the originating analyst for clarification or correction.

5.4 Critical Review Areas

• Ensure consistent sample identification numbers across all pages
• Review instrument printouts for alignment with reported results
• Evaluate chromatograms for baseline noise, peak resolution, retention time matching
• Ensure dilution factors and standard potency are correctly applied
• Confirm that specifications and acceptance criteria are referenced and met

5.5 Deviations and OOS/OOT Data Handling

1. Any Out-of-Specification (OOS) or Out-of-Trend (OOT) result must be reviewed as per SOP/QA/014/2025.
2. Document such cases using Annexure-2 and attach investigation summary if available.

5.6 Report Finalization and Approval

1. Upon successful review, sign the documentation review section on the report cover page.
2. Forward report for QA approval before issuance.
3. File the completed review checklist with the report (Annexure-1).

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• OOS: Out-of-Specification
• OOT: Out-of-Trend
• ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

7. Documents

1. Pre-Report Review Checklist – Annexure-1
2. OOS/OOT Review Log – Annexure-2

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• 21 CFR Part 211: cGMP for Finished Pharmaceuticals
• MHRA GxP Data Integrity Guidance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Anjali Reddy	Rahul Mehta	Dr. Harshita Goyal
Designation	AMD Analyst	QA Officer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Pre-Report Review Checklist

Checklist includes: raw data presence, sample ID verification, chromatogram quality, instrument log review, calculation correctness, correction justification, reviewer comments.

Annexure-2: OOS/OOT Review Log

Sample ID	Observation	Type (OOS/OOT)	Action Taken	Investigation Ref	Status
AMD/VAL/2025/47	Impurity 1 out of limit	OOS	Investigation initiated	INV/AMD/008	Open

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Checklist added, expanded data integrity checks	Annual SOP Review	Dr. Harshita Goyal
15/08/2022	1.0	Initial Issue	New Procedure	QA Head