Technical data/sections of Dossier

The technical documentation involves primary documentation which supports an NDA or ANDA in the form of a DMF/ CTD. It compiles the Chemistry, Manufacturing and Controls (CMC) information for the drug substance, as per instructions mentioned in guidance documents from the US Food and Drug Administration (FDA) or the International Conference on Harmonization (ICH). The electronic version of full DMF is submitted to the international associated regulatory agency.

The information to be included is the summary of the manufacturing procedure (in the form of a flow diagram) which provides the identification of key raw materials, solvents, and intermediates used during the process. Secondly, analytical methodology used to assess the drug substance is of critical importance. Moreover, validation reports for the methods for assay, impurities and residual solvents are also included.

The comprehensive documentation of DMF involves the following scenarios :

• Preparation of USDMF/EDMF on CTD format & writing of Quality Overall summary (QOS)
• Manufacturing and Characterization part of DMF
• Process validation, AMV & Stability Studies
• Specification, Method of analysis & Certificate of Analysis of Raw materials
• Specification, Method of analysis & Certificate of Analysis of API
• Response to MOH/FDA Queries
• Technical Package of APIs/intermediate/Bulk Drugs