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

T = Track Phase: Monitor and requalify

Once a vendor is qualified, the process does not end. The vendor's performance must be monitored on a continuous basis. The monitoring process involves a review of any problems associated with the good or service supplied by the vendor. A schedule is determined so that each qualified vendor is requalified on a periodic basis (whether a critical or noncritical vendor type) and in accordance with the most recent vendor practices. Similar to regulatory authority audits (e.g., FDA audits), the pharmaceutical or biopharmaceutical company should not only run through the preapproved audit verification steps, but should also revisit items that were found to be deficient during previous audits to make sure that any corrective and preventive actions commitments by the vendor have been implemented satisfactorily. All vendor qualification activities (i.e., qualification, requalification, and disqualification) should be documented in a vendor information file.


Throughout history, the concept of caveat emptor has been the bane of many consumers. Even though there have been some protections provided by legislature, this has not stopped the headaches, the loss of time, and the loss of money from substandard goods or services. Just as an individual consumer has the responsibility for verifying the quality of goods and services he or she plans to purchase, pharmaceutical and biopharmaceutical companies are responsible by regulation as well as through moral obligation to ensure that their vendors will consistently provide raw materials and components, compliance consulting services, manufacturing equipment, etc., that yield safe and effective drugs and other therapeutic products.

Additional Reading

1. Code of Federal Regulations (CFR), Title 21, Food and Drugs, Current Good Manufacturing Practices for Finished Pharmaceuticals (Food and Drug Administration, Department of Health and Human Services, April 1, 2006), Part 211,, accessed Sept. 18,2009.

2. CFR, Title 21, Food and Drugs, Current Good manufacturing Practices in Manufacturing, Processing, Packing or Holding of Drugs; General (Food and Drug Administration, Department of Health and Human Services, April 1, 2006), Part 210,, accessed Sept. 18, 2009.

3. George J. Grigonis, Jr., et al., "Technical Report No. 32 – Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations," PDA Jo. of Pharm. Sci. and Tech. 58 (5), 6–152 (Sept./Oct. 2004).

4. Liz Michalski, "Audits Aren't Enough to Ensure Quality," Pharm. Tech. 25 (4) 74–76 (April 2001).

Nancy Cafmeyer is a project manager and Jonathan M. Lewis* is a principal at Advanced Biomedical Consulting (ABC), PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 888.316.7537,

*To whom all correspondence should be addressed.


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