Development (AMD) department. This ensures that data generated during method development is accurate, complete, traceable, and meets regulatory expectations.

2. Scope

This SOP applies to all personnel involved in generating, reviewing, and approving analytical method development data for APIs, intermediates, and finished products within the AMD department.

3. Responsibilities

• Analytical Scientist: Ensures all development data is documented in a timely, legible, and accurate manner with traceable entries.
• Reviewer (Team Lead or Designee): Conducts detailed verification of raw data, calculations, chromatograms, and summary reports.
• QA Personnel: Audits the data for compliance with GMP and data integrity principles (ALCOA+).
• Head – AMD: Provides final approval of method development summary and ensures readiness for validation.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring the completeness and accuracy of development data and for approving the use of developed methods for validation or regulatory submission.

5. Procedure

5.1 Data Entry and Documentation

1. Use bound notebooks or validated electronic systems for recording all method development experiments.
2. Include:
   • Trial objective
   • System and method conditions
   • Instrument settings
   • Sample preparation details
   • Chromatographic/spectroscopic outputs
3. Document entries with initials, date, and unique page reference. Record electronically generated results using Annexure-1: Method Development Data Entry Template.

5.2 Primary Review (Scientific Review)

1. Performed by Team Lead or Senior Scientist not involved in data generation.
2. Check for:
   • Method conditions used
   • Peak integrity and resolution
   • Consistency across injections
   • Calculation accuracy
3. Ensure traceability of reagents, working standards, instrument calibration records.
4. Summarize review comments in Annexure-2: Data Review Checklist.

5.3 Data Integrity and GMP Review

1. QA verifies:
   • No overwriting or missing pages
   • Proper sign/date entries
   • Raw data matches processed reports
   • Audit trails (if electronic)
2. Confirm data complies with ALCOA+ principles:
   • Attributable
   • Legible
   • Contemporaneous
   • Original
   • Accurate
3. Record QA remarks in Annexure-3: Data Integrity Verification Log.

5.4 Approval and Archival

1. Following reviews, compile:
   • Method Development Protocol
   • Final Summary Report
   • Validated Graphs and Chromatograms
2. Submit for approval by Head – AMD using Annexure-4: Development Data Approval Record.
3. Approved methods can proceed for validation protocol preparation.
4. Archive originals in central AMD records room with access log.

5.5 Handling Observations and Corrections

1. If discrepancies are found:
   • Mark correction with a single line strike-through
   • Record reason, initials, and date near correction
   • Corrective entries must not obscure original data
2. Document significant discrepancies and resolution using deviation form SOP/QMS/045/2025.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available

7. Documents

1. Method Development Data Entry Template – Annexure-1
2. Data Review Checklist – Annexure-2
3. Data Integrity Verification Log – Annexure-3
4. Development Data Approval Record – Annexure-4

8. References

• ICH Q14 – Analytical Procedure Development
• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 996 – Good Practices for Pharmaceutical Quality Control Laboratories
• MHRA Data Integrity Guidance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Method Development Data Entry Template

Date	Analyst	Method Code	Objective	Conditions Used
10/05/2025	Rajesh Kumar	AMD/045	Determine degradation separation	HPLC, C18, 0.1% TFA

Annexure-2: Data Review Checklist

Item	Reviewed?	Comments
Chromatogram Peak Integrity	Yes	All resolved
System Suitability Compliance	Yes	RSD within 1.5%

Annexure-3: Data Integrity Verification Log

Document	Integrity Check	Findings	QA Reviewer
Notebook Entry 12–18	Pass	No anomalies	Sunita Reddy

Annexure-4: Development Data Approval Record

Method ID	Approved By	Date	Remarks
AMD/045	Dr. Vinay Pawar	15/05/2025	Ready for validation

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added Annexure-4 and electronic data audit trail checks	Regulatory inspection finding