Adrian L. Bone
Senior Advisor
IPEC Europe
Brussels, Belgium

Abstract

European pharmaceutical manufacturers and excipient suppliers are facing stricter regulatory requirements, including risk assessments on GMP and obligatory quality agreements, to prove the quality of their products. Certification schemes applied to excipient suppliers are one solution to reduce the burden this additional
oversight poses.

INTRODUCTION

The pharmaceutical industry, including how excipient suppliers are overseen, is experiencing extra scrutiny in Europe today. Following a number of incidences of contamination and counterfeiting of medicines entering the legitimate supply chain over the years, there is an increased focus going beyond finished pharmaceutical products to the components that make up these finished products: namely active pharmaceutical ingredients (APIs), and, more recently, excipients. This greater emphasis by regulators reflects the recognition that excipients, as well as APIs, play an important role in the overall quality of the medicines and, therefore, that they have the potential to impact patient safety. It is for these reasons that pharmaceutical manufacturers and their excipient suppliers make their own contributions to ensure the integrity of the pharmaceutical supply chain.

EXCIPIENT ‘REGULATIONS’

In recent years, three regulatory references which impact excipients have been introduced or strengthened: the European Union (EU) Falsified Medicines Directive (2011/62/EU), which came into force 21 July 2011; the EU Gui ...