Supplier Qualification more and more in the Focus of Authorities

The authorities place increasing emphasis on the continuously growing challenges of the global supply chain and its supervision. The US-American Food and Drug Administration (FDA), e.g., presented a package of measures in the last few months:

  • Food and Drug Administration Globalization Act of 2009
  • Safer Medical Products Initiative
  • Secure Supply Chain Programme
  • FDA Beyond Our Borders Initiative 
  • Opening offices in China, India and Europe
  • Planned opening of offices in South and Central America

However, since the FDA's capacities are not unlimited, Hogan & Hartson LLP e.g. expect in an article in the Regulatory Affairs Journal of April 2009 that, in its inspections, the FDA will direct its attention increasingly to the question of how the firms qualify their suppliers. This expectation is already reflected by the first warning letters. One selected warning letter says e.g.:
"Your vendor qualification program should provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. Suppliers should be monitored and regularly scrutinized to assure ongoing reliability. It is your responsibility to ensure that raw materials received are suitable and approved by the quality unit prior to use."

But also the European legislator and the corresponding supervisory organs take this subject very seriously. For example the AMWHV (German Ordinance for the Production of Medicinal Products and Active Substances) requires that the qualification of suppliers of starting materials and primary and secondary packaging materials must be carried out according to procedures fixed in writing. The qualification must generally include the conduct of on-site audits through sufficiently trained personnel of the medicinal products manufacturer. In case of commissioned activities (e.g. contract manufacturing, contract laboratories) §9(2) requires the customer to ascertain that the contractor performs the activity in compliance with the predefined instructions. With this, the AMWHV implements requirements laid down in EU law. Here, the EMEA is even more specific and calls for the conduct of audits of API (active pharmaceutical ingredients) suppliers every 2-3 years (Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials). Besides, the requirements of Chapter 5 of the EC GMP Guide are meant to be expressed in more concrete terms in the planned upcoming revision.

Even if the supervisory authorities usually refrain from gaining insight into the audit reports, within the framework of the inspection they expect at least the documented proof that the supplier is up to the customer's expectations and that regulatory requirements are fulfilled.

So the requirements on the qualification of suppliers, contract manufacturers and contract laboratories should not be underestimated. However, in the meantime, a so-called "audit tourism" has established itself, and suppliers as well as other service providers are regularly audited by their customers. This consumes an enormous amount of time and money both on the part of the auditee and on the part of the auditor, i.e. the customer.

In the ECA Education Course on Efficient Supplier Qualification (Prague, Czech Republic, from 18-19 March 2010, ) you will get to know all relevant aspects to implement and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements. You will also learn how to use a risk based approach while planning your audits.


Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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