Appropriate GMP for pharmaceutical Excipients

Objectives

This course addresses the principles of appropriate GMP and GDP as laid down in the European Guideline on the formalised risk assessment for ascertaining the appropriate GMP for excipients. It aims to explain how to implement these principles to meet the requirements of the Guideline and the authorities’ expectations. Specialists from the industry and authority will share their expert knowledge on all important aspects with respect to appropriate GMP/GDP for pharmaceutical excipients.

You will learn

• how appropriate GMP and GDP standards for excipients should look like,
• how to perform a formalised risk assessment for pharmaceutical excipients,
• how Quality Agreements between excipients suppliers and customers should be designed,
• how the oversight of complex supply chains can be kept and what to do when an audit is not possible,
• what authorities expect regarding excipients qualification.

Background

According to the EU Directive 2001/83/EC all active pharmaceutical ingredients used in pharmaceutical manufacturing must be produced in compliance with current Good Manufacturing Practice (cGMP). However due to the complexity of the supply chains GMP and GDP requirements for excipients should be appropriate and not simply mirror those developed for APIs. Article 47 of Directive 2001/83/EC provides that “The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients…” These guidelines are referred to in the second paragraph of point (f) of Article 46 of the Directive.

In March 2015 the Commission has published such Guidelines entitled “Guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use” according to which the manufacturing authorisation holders have now to perform a formalised risk assessment of the excipients used in their drug products and of the excipients manufacturer where they purchase the excipients. Based on this a control strategy has to be established in order to manage and mitigate the risks of use of the excipients.