FDA focuses more on Supplier Qualification

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:

  • "Your vendor qualification has not provided adequate evidence that the manufacturer can consistently supply raw materials that meet appropriate quality attributes."
  • "SOP [...] requires your firm to audit your medical gas supplier every... However, your firm has not conducted audits of your supplier of …"
  • "Suppliers are not monitored and regularly scrutinized to ensure ongoing reliability. Specifically, your firm has not adequately qualified the supplier of […] API. There is no assurance that the API suppliers are in compliance with CGMPs, without supplier qualification."
  • "You did not specify how you intend to document and implement such audits"
    "Your firm accepts suppliers' certificates of analysis (COA) without having qualified the vendor"
  • "Your firm has not conducted at least one specific identity test and has not established the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals"
  • "In addition, you failed to appropriately validate your suppliers' test results (as furnished to you on the suppliers' certificates of analysis) at appropriate intervals"
  • "You receive a Certificate of Analysis (COA) with the component, you discard the COA without conducting any review."

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.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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