The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Tuesday | 21 October

Highlights

Practical assistance and experiences how to introduce a new intermediate manufacturer and how to deal with a new impurity in your API! Get the information from our speakers about the quality and regulatory perspective of:

• Important changes for the API industry caused by the EU Pharmaceutical Legislation Reform
• Handling revisions of CEPs at EDQM
• API Changes: Validation and Implementation

Objectives

This ECA course provides an overview of the EU Pharmaceutical Legislation Reform and its impact on the API industry – from a regulatory and GMP point of view. During interactive sessions you will get to know:

• Which GMP and regulatory aspects have to be considered to successfully submit a change
• How to introduce a new intermediate manufacturer
• How to deal with a new impurity in your API and what actions have to be taken
• How to define critical quality attributes, critical process parameters, critical material attributes and an accurate control strategy

Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion during the so-called break-out sessions.

This ECA course ideally complements the following 28th APIC/CEFIC Global GMP & Regulatory API Conference.

Background

The API world is changing rapidly. Nowadays, changes are a daily business in the API industry. Companies are struggling with the challenge of how to implement the new regulations and requirements caused by e.g. reforms of the guidelines. To ensure the quality of their products throughout their life cycles, API changes need to be validated, submitted and implemented successfully. On the one hand, the theoretical obligations need to be considered and well known, while on the other hand the practical implementation needs to be beneficial and manageable in day-to-day API work.

Hot topics are presented in three lectures and two case studies. Additionally, you will have the chance to discuss your own topics with the speakers during the break-out sessions. Besides explaining the requirements of the guidelines of e.g. the revised variations guideline, for the respective themes, the speakers will share their approaches, experiences and best practices on these API related quality and regulatory topics.

Target Audience

This ECA course is designed for all persons involved in the manufacture of APIs, especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry as well as GMP inspectorates.