New Synthetic Approach for Manufacturing of Iron Salt and Calcium Salt

Abstract

Indian pharmaceutical industries comprises of a pool of manufacturers involved in manufacturing of ingredients, formulations, primary packaging and supply chain. They are spread across micro, small, medium as well as large enterprises. All of them have to cater to generic quality standards. This makes it challenging for some of the industries to ensure regulatory compliance. The regulators demand paradigm shift from product knowledge to process knowledge. All these, together makes it challenging for the industry to sustain growth. The study aimed at reviewing the literature for the use of operational excellence as a medium to achieve higher regulatory compliance. It reviewed the impact of operational excellence on various pharmaceutical industries, the challenges they would encounter to implement it. Some enablers and driving forces for the implementation of operational excellence were also reviewed. All this together, assisted an organization to plan a roadmap and assess its performance towards operational excellence finally leading to enhanced regulatory compliance. On the basis of this literature review, the rationale of the study was to make active pharmaceutical ingredient (API) manufacturing industry operationally excellent. Here, Quality by Design (QbD) as an approach to synthesize an iron salt and a calcium salt was explored. The primary objective of the study was to find new synthetic approach for the manufacturing of API. The scope of the study was expanded to an iron salt (Ferric ammonium citrate) and a calcium salt (calcium orotate). The secondary objective of the study included theoretical comparison of the new synthetic approach with other conventional methods and find the most operationally excellent one thus, ensuring higher regulatory compliance. The work was first performed on iron salt. Ferric ammonium citrate was the salt under study. The challenges to manufacture this salt were reviewed and QbD approach was applied. Key starting material to manufacture the salt were reviewed.