support is provided throughout the formulation and process development lifecycle, enhancing efficiency, quality, and regulatory compliance.

2. Scope

This SOP applies to all phases of pharmaceutical product development—from pre-formulation through to process optimization—where analytical method development support is required. It covers communication workflows, shared documentation, timelines, and integration meetings between AMD and PD teams.

3. Responsibilities

• AMD Scientist: Provides analytical inputs, develops and validates methods in alignment with PD timelines.
• PD Scientist: Shares formulation/process changes and samples for analysis and feedback.
• Project Manager: Coordinates schedules, meetings, and documentation tracking.
• Head – AMD & Head – PD: Approve joint development strategies and resolve cross-functional issues.

4. Accountability

The Heads of AMD and PD are jointly accountable for ensuring synchronized project execution, effective documentation exchange, and resolution of integration-related delays or conflicts.

5. Procedure

5.1 Project Initiation and Planning

1. During pre-formulation stage, AMD and PD teams shall meet to define:
   • Analytical Target Profile (ATP)
   • Sample requirements
   • Initial test methods for excipients and API characterization
   • Key milestones and deliverables
2. Document all decisions in Annexure-1: Joint Development Kick-Off Meeting Record.

5.2 Analytical Support During Formulation Trials

1. AMD shall support:
   • Compatibility studies
   • Blend uniformity tests
   • Dissolution profiling
   • Assay and impurity monitoring
2. PD shall provide:
   • Sample matrix and formulation trial information
   • List of excipients and target attributes
3. All analysis requests must be routed through Annexure-2: Analytical Work Request Form.

5.3 Method Development Alignment

1. AMD team will:
   • Develop robust methods for assay, dissolution, degradation, and content uniformity
   • Ensure methods align with proposed formulation matrices
   • Perform forced degradation to support formulation robustness
2. Developed methods shall be shared with PD using Annexure-3: Method Summary Sheet.

5.4 Review and Communication

1. Weekly cross-functional meetings to be conducted and documented in Annexure-4: AMD–PD Meeting Log.
2. Agenda includes:
   • Progress updates
   • Pending analysis
   • Change in formulation/process parameters
   • Pre-approval document finalization
3. Escalation matrix to be used in case of delays or non-alignment.

5.5 Data Sharing and Version Control

1. All analytical reports and method versions must be:
   • Reviewed by QA
   • Controlled via Document Management System (DMS)
   • Shared with PD using controlled copies only
2. Track version updates in Annexure-5: Method Version Control Register.

5.6 Completion and Handover

1. Upon project closure:
   • Finalized methods and reports archived
   • Method Validation Protocols prepared for Technology Transfer
2. Conduct a closure meeting using Annexure-6: Project Closure and Handover Form.

6. Abbreviations

• AMD: Analytical Method Development
• PD: Product Development
• ATP: Analytical Target Profile
• DMS: Document Management System
• QA: Quality Assurance

7. Documents

1. Joint Development Kick-Off Meeting Record – Annexure-1
2. Analytical Work Request Form – Annexure-2
3. Method Summary Sheet – Annexure-3
4. AMD–PD Meeting Log – Annexure-4
5. Method Version Control Register – Annexure-5
6. Project Closure and Handover Form – Annexure-6

8. References

• ICH Q8 – Pharmaceutical Development
• ICH Q10 – Pharmaceutical Quality System
• WHO Technical Report Series 1019, Annex 2 – Collaborative Approaches in Development

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Joint Development Kick-Off Meeting Record

Date	Product	AMD Lead	PD Lead	Key Decisions
01/05/2025	FORM-X	Sunita Reddy	Ajay Mehra	Defined ATP, Sample Plan

Annexure-2: Analytical Work Request Form

Date	Requested By	Sample Description	Test Required	Target Date
05/05/2025	PD Team	Trial Batch-3	Assay & Dissolution	08/05/2025

Annexure-3: Method Summary Sheet

Method Name	Parameter	Version	Validated (Y/N)
HPLC for FORM-X	Assay	V1.1	Yes

Annexure-4: AMD–PD Meeting Log

Date	Attendees	Agenda	Action Items
10/05/2025	AMD & PD Team	Method Progress	PD to share final excipient list

Annexure-5: Method Version Control Register

Method Name	Version	Effective Date	Revised By
FORM-X Dissolution	V2.0	12/05/2025	Rajesh Kumar

Annexure-6: Project Closure and Handover Form

Product	Final Report Date	Validated Methods	Handover Status
FORM-X	18/05/2025	Assay, Impurities, Dissolution	Completed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added annexures and clarified PD–AMD meeting frequency	Project audit improvement