The globalisation of manufacturing and the move to the use of mainly Asian suppliers increases the complexity and vulnerability in the pharmaceutical supply chain.
As a consequence, compliance of suppliers and the challenges in all stages of purchasing, manufacturing and distribution is getting more and more in the focus of inspectorates. As many sites of manufacturers are located in different climatic zones and/or where transport infrastructure may be difficult, the challenges arising from transport between such sites and from these sites must also be considered.
New guidance is currently implemented by the FDA and the EU and the principles of quality risk management are expected to be applied on a product by product basis in each stage of manufacture and transport - including a sufficient supplier qualification.
Reviewing FDA's warning letters of the last fiscal year (2010) reveals that supplier qualification and the management of the supply chain is also an important part of inspections. The main concerns refer to the quality of supplier qualification and the acceptance of Certificates of Analysis as the following excerpts show:
Recognising this need for further professional knowledge development, the European Compliance Academy (ECA) has set up a course on Supplier Qualification: Integrated and Efficient Supplier Qualification in Prague, Czech Republic, from 14-15 April 2011 with an optional pre-course Session on 13 April 2011: What you need to know about Suppliers in China and India.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)