Successful PRE-APPROVAL INSPECTION FOr uip
THE UNIVERSITY OF IOWA PHARMACEUTICALS PASSED A PRE-APPROVAL INSPECTION FOR AN ASEPTICALLY FILLED STERILE DRUG PRODUCT.
On August 27, 2009, the Kansas City District Office of the Food and Drug Administration (FDA) submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture an aseptically filled sterile drug product for a commercial client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into a vial. This recommendation came after an FDA Pre-Approval Inspection (PAI) of UIP’s facilities and procedures and review of the product’s manufacturing and testing procedures described in the product’s NDA. The inspection covered general GMPs as well as specific information related to the manufacture and analytical testing of the product. This FDA approval represents the second approval for UIP to provide manufacturing and/or testing services to a client in support of a commercial product this year. UIP looks forward to continuing to work with client organizations to support their formulation development, clinical trial and commercial product manufacturing and testing needs.
OTHER NEWS & Events
For a limited time: UIP is offering special pricing on lyophilization cycle development services. Read More...
September 2009: UIP has completed installation of a Lyotherm 2 and Lyostat 2 for use in lyophilization cycle development. Read More...
August 2009: UIP has completed qualification of a new Flexicon FP50 Aseptic Filling and Stoppering Machine for use in our Clean Room that serves our Hull 48 square foot lyophilizer in the Sterile Products department. Read More...
July 2009: Renovation of an additional approximately 1,000 square feet of newly acquired space in UIP’ building at the Oakdale Research Park nears completion. Read More...
June-July 2009: In a letter dated June 15th from the Kansas City District Office of the FDA, UIP received notice that based on the results of our most recent GMP inspection (March and April of 2009) the Kansas City District has recommended that a client’s ANDA is approvable. Read More...
June 2009: UIP purchased a Minncare Dry Fog System which is
currently being qualified for use in the Sterile Products department. Read More...
OVERVIEW
The University of Iowa Pharmaceuticals (UIP) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States.- UIP has been developing formulations, manufacturing products, and conducting analytical testing in compliance with current Good Manufacturing Practices (cGMPs) for over 30 years.
- The facility is the only one of its kind offering the range and scope of services needed by commercial clients.
- Virtually every type of dosage form can be produced.
- UIP serves a broad spectrum of clients of all sizes in the pharmaceutical and biotechnology industries and has performed work for pharmaceutical companies throughout the United States and the world. Additionally, UIP has performed work for numerous government agencies, including the National Cancer Institute, the Centers for Disease Control, the World Health Organization, the National Institutes of Health, and the Food and Drug Administration.
- UIP is an FDA-registered facility compliant with 21 CFR parts 11, 210, and 211, licensed by the DEA to handle controlled substances (Schedules I - V), capable of handling potent/cytotoxic materials, and capable of working with certain radiolabeled materials.
- UIP has produced numerous products for use in the EU, been inspected by the EMEA and passed numerous QP audits.
CONTACT US
Please call or send an e-mail to discuss project needs, schedule a visit and tour, or audit our facilities and procedures. For more information please contact either of the following contacts:
Mickey L. Wells, Ph.D.,
Director
E-mail: mickey-wells@uiowa.edu
Randy R. Yeates, R. Ph., M.B.A.,
Asst. Dir. Business Development
E-mail: randhall-yeates@uiowa.edu
The University of Iowa Pharmaceuticals
College of Pharmacy
115 South Grand Avenue, G-20
Iowa City, Iowa 52242
Phone: (319) 335-8674
Fax: (319) 335-9418