Conference: GMP Compliance Trends in Analytical Laboratories/Outsourcing in Pharmaceutical Laboratories

Background & Objectives

It is the aim of this course to address GMP compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP-/FDA-Inspections.

Furthermore, this conference will highlight the wide range of regulatory requirements and practical aspects that need to be considered when testing on a contract basis. The conference in particular addresses topics that are relevant from a GMP point of view.

Due to changing regulatory requirements, pharmaceutical quality control units are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US. Laboratory Managers and Analytical Scientists must be familiar with the different GMP-related topics and must be aware of the latest updates and the current interpretation.

Outsourcing is one of the critical process in the pharmaceutical industry. According to the EU GMP Guidelines (Chapter 7 – Outsourced Activities) “any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The Quality Management System of the Contract Giver must clearly state the way that the Qualified
Person certifying each batch of product for release exercises his full responsibility.”

There are various reasons for outsourcing analytic testing. Tests are sometimes outsourced only for specific projects. However, the analyses are sometimes conducted externally for each batch of a product in routine quality control, for example if the manufacturer does not have the necessary know how or the required capacity.

This conference therefore deals with the following topics:

• Data Integrity
• Regulatory and legal requirements
• Business Continuity
• Selection and management of partners
• Practical aspects to consider when establishing contracts
• Auditing contract laboratories