FDA GMP changes would require more extensive investigations of out-of-spec lab results.

FDA GMP PROPOSAL WOULD REQUIRE WRITTEN PROCEDURES FOR OUT-OF-SPEC INVESTIGATIONS as one of several proposed changes to the current Good Manufacturing Practices regulations for finished pharmaceuticals, according to a May 3 Federal Register notice. The comment period for the proposed rules runs until Aug. 1. FDA proposes that Section 211.192(b) be amended to require written procedures for investigation and determination of the cause of any failure, discrepancy or out-of-specification laboratory result.