Development of General Guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA)

Abstract

Abstract ⎯ Consent Decrees have been very popular lately. The consent decree mandates that a company start initiating change, and that change is usually associated with the way the company is manufacturing a product; and, it will involve the company re-constitute the manufacturing practices to bring it in alignment with the Food and Drug Administration (FDA’s) Good Manufacturing Practices. This project main purpose is to give guides on how pharmaceutical industries should react when a Consent Decree is given. Based on all information gathered from different sources, the consequences that bring the consent decree, the review of FDA inspectional process, and the hints required to effectively interact with the FDA are given. Finally, the guide will assist the companies to manage important events regarding compliance with the Good Manufacturing Practices and with the requisites of the consent decree. Key Terms ⎯ cGMP, consent decree, FDA inspections, regulatory issues, warning letters.