Pharmaceutical Consulting Services, LLC announced today the projected launching of their Supplier Qualification Program scheduled for January 1st, 2009. The program is a coordinated effort between PCS of California, Val Qual International, Inc. of Florida, and Midwest NutriServe of Indiana.
The program offers an inexpensive alternative to meeting the new Dietary Supplement GMP Regulations required under 21 CFR 111.75 which states that manufacturers must qualify their suppliers by establishing the reliability of a supplier’s certificate of analysis. This generally is done by retesting each material via a third party or in-house laboratory and comparing such test results to the original C of A.
The cost of qualifying vendors can be enormous. Manufacturing companies may have as many as 500 or more raw materials that they purchase from suppliers. The average cost of testing is about $300 per material. If the manufacturer purchased each material from only one source (which is unusual), the cost to qualify all suppliers and their supplied materials would be $150,000. In addition, the new GMPs require manufacturers to periodically re-qualify their suppliers meaning that this expense could be repeated every year.
The Supplier Qualification Program tests the materials from suppliers only once for all of the manufacturers who buy the material. Documentation and Certificates are issued by PCS to the manufacturers for a small fee. Currently, the fees are $50 per certificate, reducing the cost from $150,000 to $25,000. Certificates will be issued as needed by the manufacturer so the cost is amortized over a period of time.
Suppliers also benefit from the program. Suppliers will no longer be inundated by requests from their customers to qualify them. Suppliers will also be responsible for the cost of the testing. However, PCS will handle all of the testing contracts, documentation, and certification, and a portion of certificate fees go back to the supplier representing a revenue source for the suppliers. A supplier will break even by supplying a material to 20 customers. Beyond 20 customers represents a profit to the supplier.
The idea of this program is the “brain-child” of Jaye Gibbs with Midwest NutriServe. The procedures and organization was done by Gary Callahan of PCS and was reviewed by Jaye Gibbs and Dr. Shib Mookherjea of Val Qual International.
“PCS is unique in that we create programs that simplify regulatory requirements while enhancing the operational environment for manufacturers.” says, Gary Callahan, President and CEO of Pharmaceutical Consulting Services, LLC. “Our GMP Compliance Programs just make good business sense. If they didn’t, we wouldn’t have any clients.”
Other programs offered by PCS include a GMP Compliance Program, GMP Maintenance Program, and full service consulting. PCS partners with other consulting companies such as Val Qual International and Midwest NutriServe.