WHO TRS (Technical Report Series) 970, 2012 Annex 3

Sathyanarayana M.Sc.

WHO TRS (Technical Report Series) 970, 2012 Annex 3

Pharmaceutical development of multisource (generic) finished pharmaceutical products – points to consider

1. Introduction:

The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies provide scientific understanding to support the establishment of specifications and manufacturing controls.

This document focuses on the development of multisource finished pharmaceutical products (FPPs) which are intended to be bioequivalent to the relevant comparator product. Multisource FPPs should1 accordingly be therapeutically equivalent to the comparator product.

This document provides a structured approach for industry following the International Conference on Harmonisation (ICH) common technical document (CTD) format, for developing high-quality, multisource FPPs. The ICH-CTD structure for pharmaceutical development information allows for a logical, progressive description of the development process.

The document is also intended to provide assessors and inspectors with a good understanding of best practices in the development of multisource FPPs and their manufacturing processes.

Manufacturers who have chosen a more systematic approach to product development would follow the development within the broader context of quality assurance principles, including the use of quality risk management and pharmaceutical quality systems.

This document is designed to be used in conjunction with other WHO guidelines and guidance documents (1).

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Table of contents

WHO TRS (Technical Report Series) 970, 2012 Annex 3:

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