support product development and regulatory submissions.

2. Scope

This SOP applies to the Analytical Method Development department responsible for developing methods for active pharmaceutical ingredients (APIs), formulations, and raw materials. It covers planning of resources, timelines, strategies, risk assessments, and project tracking across the AMD lifecycle.

3. Responsibilities

• AMD Lead: Responsible for drafting the master plan in coordination with cross-functional teams.
• QA Department: Verifies compliance with applicable regulatory standards and reviews the plan before approval.
• Head of Department (HOD): Reviews and approves the AMD Master Plan.
• Team Members: Provide input regarding scope, timelines, instrumentation, and risk management.

4. Accountability

The Head of Analytical Development is accountable for ensuring timely preparation, execution, and control of the AMD Master Plan, ensuring alignment with corporate objectives and regulatory expectations.

5. Procedure

5.1 Collection of Preliminary Information

1. Obtain information from the product development team regarding the pipeline of new drug substances and products.
2. Identify deliverables for each analytical method, including specifications, timelines, and validation expectations.
3. Refer to past development plans and historical performance data to inform planning.

5.2 Defining Objectives and Scope

1. Clearly state the objective of the AMD plan, including regulatory milestones (e.g., IND, ANDA, NDA submission).
2. Specify scope for:
   • Raw materials
   • APIs and intermediates
   • Finished products
   • Packaging materials, where applicable

5.3 Risk Assessment and Resource Planning

1. Conduct a risk assessment based on:
   • Complexity of the method (e.g., LC-MS/MS, stability-indicating assays)
   • Criticality of the attribute (e.g., assay vs. identification)
   • Equipment availability and capability
2. Document risk assessment outcomes in Annexure-1: Risk Assessment Log.
3. Allocate required analytical resources (personnel, instruments, software) accordingly.

5.4 Timeline Definition and Milestone Mapping

1. Break down method development into stages:
   • Feasibility Study
   • Method Development and Optimization
   • Robustness and Transferability Assessment
   • Validation Readiness and Draft Protocol
2. Map each phase to project timelines using Annexure-2: Gantt Chart Planner.

5.5 Documentation Structure

1. Outline document templates and storage paths for:
   • Development Protocols and Reports
   • Validation Readiness Assessment
   • Analytical Method Transfer Documents
2. Ensure all documents are coded and indexed as per the site documentation SOP.

5.6 Finalization and Approval of Master Plan

1. Compile all the sections into a formal master plan (Annexure-3 format).
2. Submit for QA review and regulatory compliance check.
3. Obtain final approval from the Head of Department.

5.7 Plan Distribution and Implementation

1. Distribute the approved plan to all stakeholders through controlled document management systems.
2. Train AMD team members on execution aspects.

5.8 Periodic Review and Revision

1. Review the master plan every 12 months or upon major project revisions.
2. Update using controlled document change protocols and document history in Annexure-4: Revision Log.

6. Abbreviations

• AMD: Analytical Method Development
• API: Active Pharmaceutical Ingredient
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• DoE: Design of Experiments
• ATP: Analytical Target Profile

7. Documents

1. Risk Assessment Log – Annexure-1
2. Gantt Chart Planner – Annexure-2
3. AMD Master Plan Template – Annexure-3
4. Revision Log – Annexure-4

8. References

• ICH Q8(R2) – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• WHO Technical Report Series 970, Annex 2

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Risk Assessment Log

Parameter	Risk Level	Mitigation	Owner
LC-MS/MS Equipment Availability	High	Schedule backup slot	Ajay Mehra
Sample Stability	Medium	Use cold chain logistics	Ravi Nair

Annexure-2: Gantt Chart Planner

Stage	Start Date	End Date	Responsible
Feasibility Study	01/06/2025	10/06/2025	Priya Sen
Optimization	11/06/2025	25/06/2025	Arun Verma

Annexure-3: AMD Master Plan Template

Section	Description
Objective	Define method development roadmap
Scope	API, formulation, raw materials
Timeline	Mapped by Gantt chart
Milestones	Feasibility, development, validation

Annexure-4: Revision Log

Version	Changes	Date	Updated By
1.0	Initial version	01/01/2022	QA Head
2.0	Updated structure and annexures	19/05/2025	QA Head

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Updated calibration frequency and deviation logging format	Audit compliance