| Sr. No. | Project Milestones | Stage | Project Checklist |
|---|---|---|---|
| 1 | Product Identification | Product Selection | Product Initiation form |
| 2 | Product Literature Dossier(Chemistry) | Literature Review | Product Literature Dossier (Chemistry) |
| 3 | Product Literature Dossier (Analytical) | Product Literature Dossier (Analytical) | |
| 4 | Infringement analysis | Infringement analysis - Synthetic routes | |
| Raw Material Procurement | |||
| 5 | Synthetic Process Development & Optimization | Process Development (Lab) | Process Outline (SDR) |
| 6 | Analytical Method Development & Optimization | ||
| 7 | Filing Strategy | Proposed filing Strategy | |
| 8 | Indicative Stability Studies | Indicative Stability Data-Lab | |
| 9 | Benchmarking and impurity Profiling | Benchmarking Report (Innovator / Competitor) | |
| 10 | Preparation of STP and specifications | Tentative STPs and Specifications | |
| 11 | Infringement analysis of total process | Infringement Analysis Report | |
| 12 | Process validation (Synthesis) | Process Validation (Lab) | Development Report - Part A |
| 13 | Analytical method validation (Assay and OVI) | Development Report - Part B | |
| 14 | Stability studies | Stability data | |
| 15 | ‘X’ g sample to FDF / BD | 'X' g sample to FDF / BD | |
| 16 | Development Report (Safety) | Development Report - Part C | |
| 17 | Impurity profiling | Development Report - Part D | |
| 18 | Development Report (Engineering) | Development report - Part E | |
| 19 | Raw Material Procurement | Process Validation (Plant) | |
| 20 | Analytical Technology Transfer | ||
| 21 | Scale-up at Plant (Trial Batches) | Tech Transfer Report | |
| 22 | Validation Batches/Exhibit Batches | ||
| 23 | ‘X’ Kg sample to FDF / BD | 'X' Kg sample to FDF / Customer (BD) | |
| 24 | Stability/Holding time studies/Data generation | Stability Data – Plant Batches | |
| 25 | Regulatory Filing/Queries-Amendments/Variations/ | Regulatory Filing | Regulatory Approval |
| 26 | Communications with Regulatory Authorities | Regulatory Approval |
