The ANDA / NDA process, the mother of all processes, in our opinion sets the baseline for future planning, scheduling and costing. The Drug Object Model that holistically maps a particular drug product is actually an extension of ANDA / NDA, which usually stops with filing and / or approval from FDA. ADAPT goes beyond and abstracts the rules from ANDA / NDA and internalizes them into processes. The Order fulfillment process has substantial regulatory content as shown in the Figure. Here Stability process is viewed as a sub-process of the Order fulfillment process. This also ensures that the Order fulfillment process and Stability processes are ‘naturally’ integrated.

Every unconsumed drug is a liability till it is consumed. It is also very important to track for Adverse Events at a Batch level, to possibly exclude any process aberrations, before launching a full-fledged adverse event analysis.

The process is also linked to the Costing Process, where expired drugs are monitored more closely and appropriate weightage is given for expiry and risk-assessment processes.