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.
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, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=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, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=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.