Pharmaceutical Development Introduction & General Principles

Pharmaceutical Development of multi source (generic) Finished Pharmaceutical Products – points to consider:


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 multi source Finished Pharmaceutical Products (FPPs) which are intended to be bio-equivalent to the relevant comparator product. Multi source FPPs should accordingly be therapeutically equivalent to the comparator product.

This document provides a structured approach for industry following the International Conference on Harmonization (ICH) Common Technical Document (CTD) format, for developing high-quality, multi source 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 multi source 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).

1.1 General Principles:

The pharmaceutical development studies and the manufacture of primary batches are essential elements for the science and risk-based approach to establish the Critical Quality Attributes (CQAs) of the FPP and the Critical Process Parameters (CPPs) of the manufacturing process.

1.2 Scope:

This document addresses the pharmaceutical development of multi source FPPs containing existing Active Pharmaceutical Ingredients (APIs) of synthetic or semi synthetic origin. For the purposes of this document an existing API is one that has been previously authorized through a finished product by a Stringent Regulatory Authority (SRA) or, for the purposes of a National Medicines Regulatory Authority (NMRA), that has been authorized by that NMRA or for which a monograph exists in the pharmacopoeia (s) recognized by that NMRA. APIs of biological or biotechnological origin are not covered here.

This document provides guidance on the contents of a pharmaceutical development plan for multi source pharmaceutical products for both the applicants for marketing authorizations and NMRAs.

Pharmaceutical development issues depend on the API (s), the excipients, the dosage form, the manufacturing process and the container-closure system.

Pharmaceutical Development Introduction & General Principles

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