FDA finds Iowa College of Pharmacy made required corrections in its operations.(HUMAN AND ANIMAL DRUGS)

University of Iowa College of Pharmacy Pharmaceutical Service Division, Iowa City, IA Kansas City District

FDA Investigator Brent Hall conducted an inspection of the University of Iowa College of Pharmacy's Pharmaceutical Service Division (PSD) Feb. 13, 2008, to verify corrective actions required following a previous inspection in 2007.

This human/veterinary drug manufacturer makes various drug products for use in clinical trials--mainly sterile and solid dose drug products. It also provides drug development and method development services and prepares various clinical batches of drug products for use in Phase I and Phase II clinical trials. The firm no longer manufactures drug products for commercial production.

Corrections to the previous FDA-483 were verified during this inspection and appeared acceptable, Hall wrote in an EIR. No 483 was issued.

According to Mark Feldick, Assistant to the Director/ Quality Assurance Manager, the pharmacy school was in the process of validating a new automated filling machine, which was designed to significantly decrease the amount of manual aseptic filling performed. Feldick stated many of the drug products manufactured for customers were very small lots, and therefore manual operations would still need to be conducted, since starting up and operating the automated process would not be practicable. The firm was in the process of scheduling media fills using this new equipment, but hoped to begin using the new automated filing machine in the near future. The pharmacy service had also updated its Aseptic Technique in a Clean Room procedure and had conducted training of employees on the new SOP.

As indicated in a letter to the Kansas City District Office, the Pharmaceutical Service Division had terminated its manufacturing of exclusive, institutional-use only drug products. A tour through the facility, which included the firm's warehouse and storage facility, found no remaining drug products manufactured by the firm for UIHC on the shelves, Hall wrote.

The pharmacy service had revised its procedure for set-up and cleaning of clean rooms immediately after the previous inspection to address concerns that it did not use a sporicidal cleaning agent. The pharmacy also retrained its employees on the procedure.

PSD initiated several new policies to address concerns regarding written records of drug product investigations. The pharmacy had begun to trend data, including environmental monitoring data for sterile and solid products and Water for Injection (WFI) monitoring data, the FDAer wrote. These reports were to be used to identify if any corrective actions were necessary to correct or reverse a trend.

The college of pharmacy also initiated a procedure for investigating and reporting discrepancies and performing CAPA. It also initiated a procedure concerning treatment of out of specification laboratory results, which described the procedures to be followed when a laboratory error was known or suspected. This information is now forwarded to the Quality Assurance Department to assist with investigative and trending reports. These forms, along with the Viable Flora Monitoring Investigation and CAPA Report and Investigation and Corrective Action/Preventive Action Report, were being used by the quality assurance department to determine if any adverse trends were evident.

The college of pharmacy had begun gathering data to be used for annual reviews of investigational drug products and of drug products for which manufacturing processes had been validated. Feldick stated that although the firm had just recently begun compiling data for these reports, it conducted an annual review for the calendar year 2007 with the information it had for both the drug products for clinical studies and for drug products for which manufacturing process had been validated. Feldick stated future reports would be much more in depth since the 2007 reports only included the data gathered since the previous inspection.

Feldick also stated the annual product review for drug products for clinical studies would be broken down into categories such as aseptic liquid fills, lyophilized aseptic fills, terminally sterilized fills, and capsule, tablet and granulation or bulk production, rather than on individual products, since the firm may only make one batch of any given product during the year.

The firm also began conducting sterile products and general manufacturing environmental monitoring trend reports to help assist with Quality Assurance CAPA and for use in annual reports.

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