Conference: Outsourcing in Pharmaceutical Laboratories

Objectives

The aim of this conference is to highlight the wide range of regulatory requirements and practical aspects that need to be considered when testing on a contract basis. The prerequisites for release by a qualified person in the analytical contract laboratory are also covered. The conference in particular addresses topics that are relevant from a GMP point of view, such as auditing a contract laboratory, the details of contract agreements or the method transfer.

Background

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.

The qualification of contract laboratories is an essential part of the selection and subsequent cooperation. Qualified laboratories must be assessed or re-qualified on a regular interval. There are also a variety of legal requirements to consider.

This conference therefore deals with the following topics:

• Regulatory and legal requirements
• Selection and management of contract laboratories
• Practical aspects to consider when establishing contracts
• Auditing contract laboratories
• Method transfer
• Case studies
• Expectations of the authorities