PPD Development hit with 2-item 483 for analytical run flaws.(CROs/GLPs)

PPD Development, Richmond, VA, was the recipient of a two-item 483 in a 2006 audit because analytical runs were accepted even though more than two out of three quality control samples failed.

Conducting the audit from the Baltimore, MD, District Office were investigators Dianne Milazzo and John Kadavil.

The 483 stated that for the analysis of samples, PPD followed an SOP titled "Analysis of Samples Using a Validated Bioanalytical Method" that required only one-third of the replicates in each concentration be within an undisclosed percentage of the nominal concentration.

"We emphasized the importance of [undisclosed percentage] of QC samples passing at each concentration level in order to assure accurate measurement of analyte concentration in subject samples," the report noted.

Next, the EIR stated that the sponsor "did not provide objective criteria for selecting samples for pharmacokinetic repeat." Also, the reported results for sponsor-requested PK repeats ignored the original result and only compared the repeat results re-assayed.

Further, the sponsor selected samples for PK repeats which PPD reassayed. "The sponsor's SOP does not outline any criteria for the selection of samples to be reassayed for PK reasons."

The EIR also detailed the firm's training program. "The firm has an SOP which outlines the frequency and type of training the employees must attend throughout the calendar year. The firm has a training file for each employee along with two online tracking systems."

One system is used for annual training and to track SOP review by employees. This system documents the date, time, course name and completion status of the training. The other system tracks the employee training.

The FDAers randomly selected and reviewed the training records of three employees involved with one study. The SOP stated that each employee should receive training annually in GLPs, hazard communication compliance and other training areas depending on their job duties. No deficiencies were noted during this review.

Equipment calibration and maintenance also was reviewed. Records covering maintenance for several pieces equipment were reviewed. "Annual maintenance for this equipment was performed on time and per SOP," the report added.

Also, more detailed records were reviewed for March 2, 2005, in order to explain a temperature increase. "These records revealed a moderate increase that did not extend above freezing and the firm corrected this increase per SOP."

Calibration records also were reviewed, which showed bimonthly calibration was completed on time and in accordance with the SOP. No deficiencies were noted.

The firm was not able to be reached for an update. PPD Development, Richmond, VA, 10/23-27/06, Doc. 115371, $10 plus retrieval.

PPD Development, Richmond, VA, Baltimore, MD, District

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