LAYING THE CORNERSTONE
According to the FDA's July 2009 report to Congress, "The cornerstone of a prevention-focused approach in the sourcing of
ingredients or components and the manufacturing and distribution of medical products is the implementation of a quality management
system (QMS)." As with many FDA requirements, the agency does not explicitly codify how to institute such a system, but provides
only general guidance about what is expected, namely, that the QMS addresses "safety, quality, and security responsibilities
of all persons who manufacture products, including starting materials . . ." In our experience, a robust supplier quality
management system (SQMS) should include, at a minimum, some key elements.
Formal supplier qualification program: This is the foundation of an SQMS. It should define cGMP requirements and SOPs for suppliers of all kinds: CMOs, third-party
logistics providers, and component and raw materials suppliers, and should take into account through due diligence and quality
agreements these suppliers' suppliers. The supplier agreement should spell out quality standards and expectations, the communication
of out-of-specification results, and a schedule of supplier audits. The agreement also should include a requirement that suppliers
report to the company any changes in the way they do things, including their manufacturing methods and their sources of supply
and transportation. Suppliers also should be required to report to the company any FDA observations that could affect the
It's not necessary to treat all suppliers equally. Given the sheer number of suppliers that many companies employ, enforcing
the same audit schedule for all is extremely difficult. Label suppliers, for example, would not need to be audited as frequently
as the suppliers of more critical elements like raw materials or equipment. This approach not only makes the task more manageable
but also allows the company to concentrate resources and effort in areas where the risk and the return are greatest.
One should also note that when a supplier is qualified, it is qualified for a particular material or service. Just because
a supplier meets the requirements to provide one particular product, does not necessarily mean that it meets the requirements
to supply another.
Supplier quality metrics: Metrics should be focused solely on the quality and compliance performance of suppliers and considered separately from financial
measures. These metrics might include the number of rejected items, temperature excursions, right-the-first-time rate, as
well as observations from audits. Particular metrics will of course depend on the nature of the goods or services being supplied.
Continuous monitoring and follow-up: Most companies do some level of monitoring, but sometimes fail to follow up on poor performance trends or observations made
during audits. But if something is worth writing down, it is worth following up. Follow-up audits should be conducted to
determine if deficiencies have been corrected.
Supplier certification: Some companies often execute an internal supplier qualification program. These programs allow companies to formally qualify,
rank, and monitor suppliers and their products or services. Sponsor companies can have a high level of trust in suppliers
who meet and maintain the rigorous requirements of these certification programs. Conversely, these programs should contain
a mechanism for de-certification of a supplier if compliance problems arise.
For large companies, with dedicated supplier quality departments, establishing a more effective SQMS may entail only formalizing
and enforcing existing policies and procedures. For other companies, it may be a matter of expanding oversight to take into
account suppliers' suppliers or to include logistics providers in the program. Companies that lack resources may want to add
them or look for ways to use their existing resources more efficiently. Many companies, of all sizes and in all circumstances,
will draw on external consultants to do continuous monitoring and conduct audits. The advantage that these third-parties offer
is they have nothing else on their plates; they are specialists, they are objective, and they may be less expensive than internal
personnel. In any case, they should be as carefully qualified as any other supplier.
With the number of suppliers companies use, the increasing complexity of the supply chain, and increasing regulatory scrutiny,
biopharmaceutical companies can no longer afford anything less than world-class supplier quality management.
James R. Darnell, Jr. is a managing consultant at Tunnell Consulting, Inc., King of Prussia, PA, 610.337.0820, firstname.lastname@example.org