DPT Laboratories Hosts Tour for FDA's Office of Generic Drugs

PharmaManufacturing.com
08/16/2005

DPT Laboratories announced August 15 that it had recently hosted a manufacturing plant tour and knowledge-sharing visit with the Food and Drug Administration's Office of Generic Drugs (OGD) at DPT's San Antonio, Texas, facilities. The plant tour was one of two such site visits the OGD scheduled this year at drug manufacturing plants under the OGD's Plant Tours Program.

The goal of the program is to provide OGD review and support staff, from all review disciplines, with enhanced awareness of critical functions of drug product development, manufacturing, and regulatory submissions. The OGD hopes the program will foster improved communications between OGD staff and industry on issues of mutual interest.

"We're proud to have the opportunity to represent our industry by participating in this value-added program," said Gene Shimek, DPT's director of regulatory compliance. "The more we can learn from each other, the more effectively we can work together."

During their plant tour at DPT, OGD officials observed a wide range of activities, including process development and validation considerations, method development and validation considerations, process mixing techniques, component addition techniques and compounding, filling and packaging operations.

DPT Laboratories is a contract manufacturer specializing in pharmaceutical development and manufacture of prescription and over-the-counter products. In addition to San Antonio, the company has manufacturing operations in Lakewood, N.J. DPT specializes in the development and manufacture of creams, lotions, ointments, gels, solutions, suspensions and aerosols. For more information, visit DPT's website at www.dptlabs.com.