Saint Petersburg, FL – 10/22/2009) With unprecedented consumer demand for the H1N1 vaccine (i.e. the swine flu vaccine) coupled with the Food and Drug Administration's (FDA) push and relative regulatory leniency to get mass quantities of this vaccine on the market fast, the safety associated with the manufacturing of the vaccine is a viable concern for the US population.

One of the best tools that manufacturers of the H1N1 vaccine have for ensuring safety of their finished products is vendor qualification. Vendor qualification is defined as the process where a vendor is evaluated to determine if it can provide the necessary goods or services to the standards that the purchasing company requires. Basically, what is put into a product is directly proportional to the quality of the finished product. Manufacturers of the H1N1 vaccine, like pharmaceutical, medical device, and biopharmaceutical manufacturers are not only ethically required to qualify vendors providing goods and services that affect the quality of product distributed to consumers but are also required to perform vendor qualification activities in accordance with FDA's current Good Manufacturing Practice (cGMP) regulations. Vendor qualification is essential in the manufacturing of regulated products such as the H1N1 vaccine, however, the process can very time consuming, costly, and difficult to comply with.

Advanced Biomedical Consulting (ABC), LLC, a hands-on consulting firm specializing in cost-effective manufacturing, quality, and regulatory compliance services for the food, drug, cosmetic, medical device, dietary supplement, pet food, and biopharmaceutical industries has developed a new vendor qualification program that is not only implementable, compliant, and quite effective in ensuring vendor acceptability and ongoing vendor performance, but is also cost-effective as compared to current industry practices. This new methodology is known as the Q.U.E.S.T. approach to vendor qualification.

The Q.U.E.S.T. Approach (i.e. Question, Understand, Evaluate, Site Audit, and Track) recently developed by the FDA compliance experts at ABC and currently being executed and implemented at both large and small food, drug, cosmetic, medical device, dietary supplement, pet food, and biopharmaceutical companies worldwide is quickly becoming the new industry standard to implementing an effective, compliant, and cost-effective vendor qualification program.

For more information on the Q.U.E.S.T. Approach to vendor qualification or any other FDA and state compliance services, please visit the ABC website, www.abcforfda.com, or contact ABC at the address or phone number below.

ABC provides a wide range of consulting services to industries associated with the manufacturing and distribution of Food and Drug Administration (FDA) regulated products. With a diversified workforce made up of published technical and regulatory experts in the pharmaceutical, medical device/diagnostic, biopharmaceutical, cosmetic, food/seafood, and animal feed industries, ABC can provide cost-effective solutions to nearly all issues encountered in FDA regulated industries.