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Executive Summary

FDA INVESTIGATORS WILL ABBREVIATE ROUTINE INSPECTIONS of firms that have good compliance records and have not made significant operational changes. FDA headquarters recently advised its field offices that an "abbreviated" approach should be taken during routine inspections when conditions at the firm do not appear to warrant a full investigation. The abbreviated inspections will satisfy the agency's biennial inspection requirement, the new field guidance states. Procedural differences between an "abbreviated" and a "full" inspection were specified in a new section added to the drug process inspection compliance program. The agency maintains a collection of its programs called the "FDA Compliance Program Guidance Manual." The policy manual is used by field investigators and managers as a reference guide in carrying out their surveillance activities. ]EDITORS' NOTE: The new section of the drug process compliance program on abbreviated vs. full inspections, together with an in-depth analysis, is included in the March issue of "The Gold Sheet." Contact Edward Picken at (301) 657-9830 for further information.[ In an abbreviated inspection, the manual states, the FDA investigator should perform only "a brief inspection of the firm's manufacturing facility including master records and batch records in a representative number of products manufactured by the firm." FDA advises that the products selected for special attention should include those with a history of previous problems. A brief inspection of the laboratory should also be included and a spot-check made of a limited number of test records from at least one NDA/ANDA product "to assure that batches are being subjected to adequate testing for conformance to specifications." If the abbreviated inspection reveals no "significant" objectionable conditions, the new guidance states, it "is adequate for routine coverage and will satisfy the biennial inspection requirement." Reporting requirements in this case are also limited, the manual says, and need only include a brief summary describing the scope of the inspection, the persons interviewed and a description of any changes, together with a listing of any adverse findings.

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