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Efficient Supplier Qualification
18-19 March 2010
Prague, Czech Republic
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Learning Goals
During this course, you will learn all relevant aspects to implement and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.
Background
Qualification and audits of suppliers, contract manufacturers and laboratories and other service providers are an important part of each Quality System. But what is required and which steps are really necessary? And is it possible to even decrease audit activities?
According the EU Guide to GMP [5.26], starting materials should only be purchased from approved suppliers. And Directive 2004/27/EC states that the manufacturer shall only use active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials. But also in contract manufacture and analysis, the contract giver is responsible for assessing the competence of the contract acceptor to follow GMP (EU Guide to GMP [7.3]).
The requirements and efforts to qualify suppliers should therefore not be underestimated. However, it seems that a downright 'audit tourism' has grown and suppliers and service providers are audited on site frequently and sometimes too often. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers bring new challenges. This adds up to significant expenses for both the inspected and the inspecting company. |
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