FDA cites PPD Development with inadequate assay validation.Bioanalytical laboratory bioanalytical laboratory Lab medicine A place, establishment, or institution organized and operated primarily for performing chemical, microscopic, serologic, parasitologic, bacteriologic, or other tests, by the practical application of one or more of the PPD (1) (Parallel Presence Detect) The method used by earlier SIMM memory modules to communicate their capacity to the computer. A binary number coming from a parallel set of pins was read by the system, with each pin representing one bit. Contrast with SPD. Development, Richmond, VA, received a seven-item 483 for inadequate validation of assays, failure to demonstrate stability, documentation issues and an inadequate recovery experiment, after a visit from investigators of FDA's Baltimore District The inspection was carried out by investigator Candace Cortes and pharmacologists Martin Yau and Jackie O'Shaughnessy. A previous inspection in December 2001 was a "for cause" analytical audit of a bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. study, which uncovered just one deviation and was classified voluntary action indicated (VAI VAI Voest-Alpine Industrieanlagenbau (Austrian company) VAI Video As Input VAI Voluntary Action Indicated (US FDA) VAI Volleyball Association of Ireland VAI Video Assisted Instruction ), according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the EIR EIR n. popular acronym for environmental impact report, required by many states as part of the application to a county or city for approval of a land development or project. (See: environmental impact report) . The current inspection covered the facilities, procedures, analytical data and operations. Cortes noted in the EIR that the firm did not have written SOPs for the maintenance of an unnamed piece of equipment at the time of this study. Cortes also wrote that "documentation of analytical runs was incomplete." She observed missing documentation of SOPs for two pieces of equipment but noted that "operator manuals for these pieces of equipment did not reveal any mandatory preventative maintenance." Other deviations pointed out in the 483 included insufficient data during the inspection to confirm the theoretical isotope abundance factor; failure to demonstrate stability, no CAPAs and analytical and validation runs were not documented in the instrument logbook per SOP. In an interview, Nancy Zeleniak, head of Corporate Communications for PPD, said the firm provided FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. with the information it requested as quickly as possible. "We have taken care of the few deficiencies that the FDA addressed. We have moved on and are now in full compliance with the FDA," she said. Zelniak added: "FDA also asked us to try a different approach in our analytical method, which we also undertook so that the client now has two different analytical methods." PPD Development, Richmond, VA, 5/13-17/02, Doc. 109385M, $29.50 plus retrieval. [check] The Checklist--PPD [check] Validation deficiencies [check] Stability demonstration deficiencies [check] Inadequate recovery experiment |
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