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Executive Briefing Series (formerly The Food & Drug Letter)
May 18, 2012 | Full Issue in PDF Format
The careful qualification of any supplier remains the foundation for all quality agreements. Once a company has determined that it intends to outsource either the production of a material or a particular task in its production, it then must develop user requirements, with minimum product specifications. The company’s quality unit must review these requirements and evaluate its own standard operating procedures with respect to how it ensures good manufacturing practice compliance. Or, in cases of new products or processes, it must determine how it will ensure GMP compliance. Armed with this information, a company can then qualify potential suppliers against the benchmark of its own requirements. This issue of The Food & Drug Letter is the first in a two-part series on crafting pharma supplier quality agreements. It offers companies insights on qualifying suppliers, formatting an agreement, negotiating with suppliers and getting the agreement approved. Next time, F&DL will focus on what to include in specific sections of a quality agreement.
The FDA may soon issue agencywide guidance to clarify drug and device manufacturers ’ responsibilities for the quality of ingredients manufactured by contractors, agency officials say.
Each specific product or task associated with a finished drug will require a particular qualification process.
Once a company qualifies a supplier, it then needs to draft a solid quality agreement with that party.
A list of definitions is an important — and often neglected — part of the supplier quality agreement.
Though thoroughness remains important to any quality agreement, the document should not become a dumping ground for any and all requirements.
As anyone who has dealt with supplier quality agreements knows, reaching agreement unfortunately remains more difficult than it would appear on its face.
The following organizations have created quality agreements that address issues specific to their segment of the drug industry.
The correct supplier and client company officials must each have an opportunity to thoroughly review any supplier quality agreement, once it is complete.
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