Indian Stability Data Guidance

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

[b]GUIDANCE FOR INDUSTRY ON :

Requirement of Chemical & Pharmaceutical Information including Stability Study Data Before Approval of Clinical Trials / BE Studies[/b]

http://cdsco.nic.in/Guidance_for_CMC_&_Stability_Data_for_CT[1].pdf