SOP for Cross-Functional Integration with Product Development Team in the AMD Department
| Department | Analytical Method Development |
|---|---|
| SOP No. | SOP/AMD/040/2025 |
| Supersedes | SOP/AMD/040/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 19/05/2025 |
| Effective Date | 20/05/2025 |
| Review Date | 19/05/2026 |
1. Purpose
This SOP establishes the framework for collaboration between the Analytical Method Development (AMD) department and the Product Development (PD) team. It ensures that analytical 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
- 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
- Document all decisions in Annexure-1: Joint Development Kick-Off Meeting Record.
5.2 Analytical Support During Formulation Trials
- AMD shall support:
- Compatibility studies
- Blend uniformity tests
- Dissolution profiling
- Assay and impurity monitoring
- PD shall provide:
- Sample matrix and formulation trial information
- List of excipients and target attributes
- All analysis requests must be routed through Annexure-2: Analytical Work Request Form.
5.3 Method Development Alignment
- 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
- Developed methods shall be shared with PD using Annexure-3: Method Summary Sheet.
5.4 Review and Communication
- Weekly cross-functional meetings to be conducted and documented in Annexure-4: AMD–PD Meeting Log.
- Agenda includes:
- Progress updates
- Pending analysis
- Change in formulation/process parameters
- Pre-approval document finalization
- Escalation matrix to be used in case of delays or non-alignment.
5.5 Data Sharing and Version Control
- All analytical reports and method versions must be:
- Reviewed by QA
- Controlled via Document Management System (DMS)
- Shared with PD using controlled copies only
- Track version updates in Annexure-5: Method Version Control Register.
5.6 Completion and Handover
- Upon project closure:
- Finalized methods and reports archived
- Method Validation Protocols prepared for Technology Transfer
- 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
- Joint Development Kick-Off Meeting Record – Annexure-1
- Analytical Work Request Form – Annexure-2
- Method Summary Sheet – Annexure-3
- AMD–PD Meeting Log – Annexure-4
- Method Version Control Register – Annexure-5
- 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 |