Quality, Safety and Control

Objectives

This European Joint Conference is dedicated to quality and regulatory aspects of raw materials used for biological medicinal products. The following topics will be addressed

• Biological Raw Materials in Pharmacopoeias
• GMP requirements for raw materials – Guidances
• The EBE Concept paper on management of raw materials for biologicals
• Quality Control aspects of Biological Raw Materials
• Risk management and control of Biological Raw Materials, components and excipients
• Regulatory aspects, change management and life cycle approach for Biological Raw Materials

In this conference the new EBE Concept paper on management of raw materials for biologicals will be introduced and discussed.

Background

Raw materials (RM) used in the manufacture of biological medicinal products need to be well understood with respect to their role in the manufacturing process. In particular in a GMP regulated environment these raw materials, components as well as excipients require a thorough control regarding consistent quality. Therefore all critical quality attributes should be known and appropriate risk mitigation and control strategies should be established. As there are currently no written industry guidelines available dedicated to a risk-based biological raw materials management approach the European Pharmaceutical Enterprises, EBE, has developed a concept paper entitled “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products“ in which the principles of such a risk based approach is outlined.

Target Audience

This conference will be of significant value to

• Laboratory managers
• Quality control managers
• Analytical scientists
• Senior laboratory staff
• QA Units
• Qualified Persons (QPs)

This conference also addresses employees of contract labs being involved in development of methods, control testing and Quality Assurance as well as staff from regulatory affairs departments.