Preparation and Validation of CTD and eCTD for an ANDA of a Model Tablet as per USFDA Requirements

Abstract

A knowledge about the module 1 which gives description about administrative information and prescribing information, module 2 deals with summaries, ,module 3 includes a quality part like using of drug substance and finished product manufacturing process, collection process, analytical process and there reports, specification and there justification, container closers system, reference standard material, stability data, control of excipients for X product which help to pharmaceutical company to build a strong and high quality of module 3 and module 4 has nonclinical study reports and module 5 has clinical study reports which include listing of clinical studies, bioavailability/ bioequivalence reports study, comparative BA/BE reports, in vitro – in vivo correlation study reports, bioanalytical method. One of the major reasons for refusal to receive / file issued by the USFDA is the deficiency of the data in the Chemistry, Manufacturing and Control (CMC) section. So, it is mandatory to properly review and then submit the documents to the regulatory authorities. As one of the major pharmaceutical markets in the world is the United States of America (USA), its review process is very stringent and the pharmaceutical industry should follow the requirements for the commercialization of the drug product in the USA. This research help to prepare and Validate of CTD and eCTD for an ANDA of a Model Tablet as per USFDA Requirements.