Pre-Course Session: What you need to know about Suppliers in China and India

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.

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?

Starting materials should only be purchased from approved suppliers. But also in contract manufacture and analysis, the contract giver is responsible for assessing the legality, suitability and the competence of the contract acceptor to follow GMP (EU Guide to GMP [7.5]).

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 sometimes too often. In the globalising world more and more supplies are coming from countries like India and China. And qualifying these suppliers brings other challenges. This adds up to significant expenses for both the audited and the auditing company.

But supplier qualification is not limited to auditing. The whole process of supplier qualification and co-operation should be integrated in the existing Quality System of a company.