-26 78. WELLS LABORATORY, INC. FOR INTERNAL USE ONLY Audit Date: 2/8/78 Studies Audited: 7 Acutes, 1971, 1972; 6 Subacute Dermals, 1970, 1971, 1972 General Conclusions: Documentation and quality control procedures were poor General Conclusions: No raw data were available for 9/11 studies audited (prior to 1972). Numerous discrepancies noted between the final report and the pathologist's notes. The tissues listed as having been examined histologically in the final report do not agree with the pathologist's notes. The validity of the studies audited is indeterminable at this time. Any Wells Laboratory study utilized in OPP decision making should be referred to Program management for audit. FDA GLP Status: Not applicable operating at "state of the art". General Conclusions: The mouse study was invalidated by EPA reviewers on the basis of unexplained discrepancies. These were addressed in the review of the raw data. The most serious problems appear to be confusion regarding animal identification and the large number of animals (1/3 of each dose group) for which pathology reports are unavailable or blank. The validity of the other studies audited is under discussion. FDA GLP Status: Not applicable. 82. -27 FOR INTERNAL USE ONLY Audit Date: 6/79 Studies Audited: Acutes, 1969, 1977 General Conclusions: No raw data exist for studies prior to 1975. Data for one set of acutes performed in 1977 were destroyed. Raw data for other 1977 studies support the conclusions of the studies. Until further notice, all Younger studies must be audited by the sponsor April 1, 1983 THE NATIONAL LABORATORY AUDIT PROGRAM I General Purpose and Scope The National Laboratory Audit Program (NLAP) was established to provide the Office of Pesticide Programs (OPP) assurance of the reliability of scientific information submitted to support registration action on pesticide products. To discharge this responsibility NLAP schedules and conducts (1) onsite Good Laboratory Practices (GLP) inspections to evaluate the adequacy of staff, facilities, and adherence to widely accepted laboratory practices and (2) data audits to determine whether: (1) testing was performed in accordance with specified sound methodology, (2) any deviations from acceptable methodologies may have affected the reliability of the test results, and (3) the scientific data and reports fully and accurately reflected the actual test procedures followed and results obtained. These GLP inspection and data audits may be conducted concurrently or independently depending on the circumstances prompting the investigation. GLP inspections assess current operations of a facility while data audits evaluate the past performance. Both GLP inspections and data audits address the performance of the laboratory during a specific period of time and as such provide an impression of the overall performance in the area of investigation at that time. The relevance of the investigation to other test systems, other periods of time or other areas of the laboratory initiatives is questionable and subjective. 2 II Goals: The goal of the National Laboratory Audit Program is to monitor and upgrade industrial and contract pesticide testing laboratories by encouraging them to utilize established GLP practices and to adequately document and report test results. This will be accomplished by conducting periodic GLP inspections and data audits of laboratories performing pesticide testing. By the close of FY 83 all known active major pesticide testing laboratories in the United States and those known to have had previous testing problems will be scheduled for GLP inspections and/or data audits. NLAP will utilize the procedures and criteria described in this document to conduct inspections and data audits to evaluate the performance and output of the laboratories. The goal of this strategic plan is to: 1. 2. 3. establish responsibilities within the Agency to permit an effective GLP inspection and data audit program. establish an efficient and responsive program within OPP. identify the laboratories actively doing pesticide testing for registrants. 4. establish procedures to permit cataloging of studies by 5. establish systematic procedures to select and perform 6. establish data audit procedures to validate the quality 3 III Applicable Interagency Agreements and Memorandum of Agreement usually be provided by EPA's scientific staff. This agree- 1. These audits will be conducted by FDA at EPA's request within constraints of FDA program priorities and availability of trained FDA regional personnel. With appropriate delegation of authority FDA may conduct GLP inspections for EPA at laboratories which do not strictly come under FDA's purview (e.g. laboratories which test only toxic substances not regulated by FDA). FDA will provide EPA with a report for each study audited. The report will indicate discrepancies between the raw data and the laboratory report submitted to EPA or predecessor agencies. The report will be prepared |