Q2(R2) and Q14 requirements.

2. Scope

This SOP applies to all analytical methods developed in the Analytical Method Development (AMD) department for raw materials, drug substances, intermediates, and finished pharmaceutical products.

3. Responsibilities

• Analytical Scientist: Completes development trials and compiles readiness evaluation checklist and data.
• Team Lead: Reviews all scientific justifications and trial outcomes against validation criteria.
• QA: Confirms documentation completeness and regulatory compliance.
• Head – AMD: Grants approval to proceed with validation activities.

4. Accountability

The Head of AMD is accountable for ensuring that methods do not advance to validation without successful completion of the readiness evaluation process.

5. Procedure

5.1 Prerequisites for Evaluation

1. Ensure the following are completed:
   • Approved Analytical Target Profile (ATP)
   • Method Development Report
   • System Suitability Criteria Defined
   • Stability Indicating Data (if required)
   • Control Strategy Identified
2. All chromatographic or assay parameters must show consistent reproducibility over 3 or more days.

5.2 Readiness Evaluation Checklist

1. Use Annexure-1: Validation Readiness Checklist to verify that the method meets:
   • Robustness under method stress conditions
   • Linearity and accuracy in development trials
   • No unresolved issues from DoE or risk assessments
   • Proper documentation of reagents, instruments, columns
   • Repeatable system suitability performance
2. Assign status: Ready / Not Ready / Ready with Conditions.

5.3 Preliminary Performance Evaluation

1. Repeat the method under final conditions across:
   • Two different analysts
   • Two different days
   • Two instruments (if available)
2. Compare retention time, resolution, %RSD, assay values, LOD/LOQ estimates.
3. Document results in Annexure-2: Trial Summary Table.

5.4 Documentation Review

1. Ensure the following documents are approved and archived:
   • Method Development Protocol and Report
   • Trial Data and Graphs
   • Control Strategy
   • DoE Summary (if applicable)
   • Stability-Indicating Study Report
2. Fill Annexure-3: Document Verification Record before submitting to QA.

5.5 Final Approval and Sign-Off

1. Submit completed checklist, data, and supporting documents to QA and Head – AMD.
2. QA shall review alignment with applicable regulatory guidelines and provide remarks.
3. Head – AMD shall authorize validation initiation if all criteria are satisfactorily met.

6. Abbreviations

• AMD: Analytical Method Development
• ATP: Analytical Target Profile
• QA: Quality Assurance
• DoE: Design of Experiments
• RSD: Relative Standard Deviation
• LOD/LOQ: Limit of Detection / Limit of Quantitation

7. Documents

1. Validation Readiness Checklist – Annexure-1
2. Trial Summary Table – Annexure-2
3. Document Verification Record – Annexure-3

8. References

• ICH Q2(R2) – Validation of Analytical Procedures
• ICH Q14 – Analytical Procedure Development
• WHO TRS 996 – Good Practices for Pharmaceutical Quality Control Laboratories

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Validation Readiness Checklist

Item	Status	Remarks
ATP Approval	Yes	Signed on 12/05/2025
Robustness Studies	Yes	pH and flow rate evaluated
Stability-Indicating Proof	Yes	Degradation peaks resolved

Annexure-2: Trial Summary Table

Parameter	Analyst A	Analyst B	Result Comparison
RT	8.23 min	8.26 min	Consistent
Assay	99.1%	98.9%	Acceptable

Annexure-3: Document Verification Record

Document	Available	Reviewed By	Comments
Method Development Report	Yes	QA	Complete
DoE Summary	Yes	QA	Included in Appendix B

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Expanded checklist and included Annexure-2 and 3	Q14 alignment