2 . 2 Drug Product

A summary should be provided describing the development of the formulation , including identification o those attributes that are critical to the quality of the drug product , taking into consideration intended usage and route o administration .The physicochemical and biological properties relevan to the safety , performance or manufacturability of the drug product should be identified and discussed .1 ) or ICH Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnology/Biological Products . The discussion should cross-reference any relevant stability data in 3.2 .