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How to Develop a Practical (and Compliant) Vendor Qualification Program
This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.
Figure 1: The Q.U.E.S.T. approach to vendor qualification.
How does a company qualify a vendor? What approach will give the company the best probability of an accurate vendor assessment,
meet current regulatory expectations, and still remain practical? One method is by using the Q.U.E.S.T. Approach (i.e., Question,
Understand, Evaluate, Site Audit, and Track) shown in to Figure 1.
Q = Question Phase: What a potential vendor needs to supply
The first step in qualifying a vendor is for the pharmaceutical or biopharmaceutical company to document its needs from a
vendor of this type. For example, does the vendor need to sell to pharmaceutical or biopharmaceutical firms already? Does
the vendor have to have a drug master file registered with the US Food and Drug Administration? Does the vendor have the current
ability to supply the required units, resources, etc.? Of course, one of the most important questions is, "What is our budget
for this vendor's products or services?" Especially in the current economic environment, many hours, days, and weeks are wasted
by defining requirements without a real budget number established upfront. Oftentimes, a company's change-control system is
a good place to document/capture this information and overall effort to ensure understanding and commitment by all internal
parties involved.
U = Understanding Phase: How vendors meet the requirements
Once the Question Phase is complete, vendors that appear to meet the company's requirements are contacted directly to gauge
interest in being a new vendor for the company. The company's requirements (as defined in the Question Phase) are then supplied
to those interested vendor organizations. It should be requested that the vendor supply all its administrative information
(e.g., key contacts, location(s)), applicable sales and marketing materials, and most importantly, documentation that supports
its ability to meet the specified company requirements (including, but not limited to, pricing). At this time, it should also
be requested that the vendor send a "sample" of the product or service that it will potentially providing. For example, a
lactose supplier should be requested to supply samples of the lactose that it would offer for sale in addition to the certificates
of analyses for the lactose. A bioreactor supplier should provide pictures of the vessel along with all the vessel's specifications.
Even a consulting or contracting organization should provide samples. These organizations should provide sample resumes of
resources that would be involved in the pharmaceutical or biopharmaceutical company's projects.
At least three vendors should provide the information requested in its entirety before moving to the next phase in the vendor
qualification process. At this point, it is imperative that each vendor package be thoroughly assessed for adequacy and completeness
and be understood with regards to the vendor's ability to meet the company requirements specified.
Nancy Cafmeyer is a consultant at Advanced Biomedical Consulting (ABC), LLC, with over 28 years industry experience has consulted at numerous pharmaceutical, nutritional supplement, and medical device manufacturers and prior to working for ABC has held both hand-on and management positions at companies such as King Pharmaceutical, Geopharma, and Daniels Pharmaceuticals. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522.
Articles by Nancy Cafmeyer
Jonathan M. Lewis, a principal at Advanced Biomedical Consulting (ABC), LLC, has consulted at over 50 different biopharmaceutical, pharmaceutical, and medical device manufacturers and prior to starting ABC has held both hand-on and management positions at companies such as Cardinal Health, KMI, and PAREXEL International. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522
Articles by Jonathan M. Lewis
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To select processes for both new and legacy products
