How to Develop a Practical (and Compliant) Vendor Qualification Program - Pharmaceutical Technology

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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.


Pharmaceutical Technology
Volume 33, Issue 10

Vendor qualification – the Q.U.E.S.T. approach


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.


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