Stage Gate Adopted for API Development

01

Feasibility

02

Optimization & Standardization

03

Process Engineering & Safety Studies

04

Analytical Method Development and Validation

05

Crystallization & Particle Engineering

06

Vendor Qualification & Documentation

07

Genotoxic impurities & Nitroso-amine impurities risk assessment & Establishment

08

Kilo Lab & Scale up Studies

09

Exhibit Campaign as per the ICH

10

Regulatory stability studies for all zones

11

DMF filling & Packing configuration

12

Backward integration of KSMs to meet the regulatory requirements & cost

13

Development & Validation Report

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Stage Gates for API Development Process