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Labcompliance News, October 2005

October 13, 2005   

FDA's New “Drug Watch” for Emerging Drug Safety Information

This new document provides guidance on how FDA intends to develop and disseminate important emerging drug safety information concerning marketed drug products to healthcare professionals and patients. The 'Drug Watch' is intended to identify drugs for which FDA is actively evaluating early safety signals.

October 13, 2005

New Publication: The Growing Scope of Records Management

The article written by Dr. Martin Sumner-Smith Ph.D. gives recommendations on how to deal with the sheer volume of records in the pharmaceutical industry. This topic becomes more and more important because of the breadth of records that must now be kept, the increasing proportion of electronic records, and the impact of additional, new regulations from beyond the life sciences sphere (e.g. Sarbanes-Oxley).

October 13, 2005

FDA Cites Instrument Calibration and other Laboratory Controls in a Warning Letter

During an inspection in January 2005 the FDA found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for drug products. Special focus was on the laboratory control system. -The company: failed to to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance . Specifically, the firm has not performed any equipment qualification on the "mobile" cryogenic pumping system. also the procedure was found to be unclear and was inconsistent with the manufacturer's recommendation which advises to calibrate the Oxygen Analyzer each time the analyzer is moved. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.