Editorial. Proposed GLP Regulations - An ... - ACS Publications

---

analytical chemistry Editor: H e r b e r t A. Laitinen EDiTORlAL HEADQUARTERS 1155 Sixteenth St.. N.W. Washington, D.C. 20036 Phone: 202-872-4570 Teletype: 710-8220151 Managing Editor: Josephine M. Petruzzi Associate €d/tor: Andrew A. Husovsky Assooate Editor. Easton: Eiizabeth R . Rufe Assstant Editors: Barbara Cassatt. Nancy J Oddenino, Deborah C. Stewart Editorial Assistant: Andre D’Arcangelo Production Manager: Leroy L. Corcoran Art Director. John V . Sinnett

Designer: Alan Kahan Advisory Board: Donald H. Anderson, Peter Carr, Velmer Fassel, David Firestone, Kurt F. J. Heinrich, Philip F. Kane, Barry L. Karger, J. Jack Kirkland, Lynn L. Lewis, Marvin Margoshes, Harry B. Mark, Jr., J. W. Mitchell, Harry L. Pardue, Garry A. Rechnitz, W. D. Shults Instrumentation Advisory Panel: Gary D. Christian, Catherine Fenselau, Nathan Gochman, Oary M. Hieftje, Gary Horlick, Peter J. Kissinger, James N. Little, C. David Miller, Sidney L. Phillips. Contributing Editor: Claude A. Lucchesi Department of Chemistry. Northwestern University, Evanston, iil 60201 Published by the AMERICAN CHEMICAL SOCIETY 1155 16th Street, N W. Washington, D.C. 20036 Books and Journals Division

Director: D. H. Michael Bowen Editorial: Charles R. Bertsch Magazine and Production: Bacil Guiley Research and Development: Seidon W. Terrant Circulation Development: Marion Gurfein Manuscript requirements are published in the January 1978 issue, page 189. Manuscripts for publication (4 copies) should be submitted to ANALYTICAL CHEMISTRY at the ACS Washington address.

Proposed GLP RegulationsAn Opportunity to Participate I n the May issue of ANALYTICALCHEMISTRY( p 521 A), Dr. William Horwitz, of t h e Food and Drug Administration presents arguments t h a t the proposed Good Laboratory Practices (GLP) regulations of FDA repr 2sent, common sense rules for analytical chemistry in general, and not just for animal testing, toxicological, and clinical laboratories. In the same issue ( p 531 A) Dr. R3beri; M. Hodges presents the viewpoint of the research scientist in a pharmaceutical laboratory, and warns against the stifling effects of over-regulation in various operations in this industry. T h e proposed FDA regulations stress complete, detailed, and documented records of laboratory reagents, instruments, personnel, and procedures. These records are designed to permit inspectors to determine whether an experimental design, or “protocol”, has been properly executed. The regulations would apply to all scientific contributors to nonclinical (nonhuman) safety tests and specifically to analytical work on test materials, diets, and physiological samples, whether carried out in industrial or private laboratories, universities or medical schools. Interagency cooperation involving FDA, EPA, OSHA, and others, liaison contacts with NIH and NCI, and GLP inspections of foreign labs with the cooperation of foreign governments involved all point toward a widespread adoption of the G L P requirements. Furthermore, not only laboratories directly conducting such experiments, but also those supplying general analytical services, would be subject to inspection to verify compliance. No one could rationally argue against regulat,ion of laboratory practices for the execution of standardized experimental designs for routine analytical operations carried out for the purpose of protecting human health. Such operations include clinical tests on human body fluids and specimens, toxicological tests on animals, and the like, where some type of quality control is needed to protect the public. Neither can one criticize the desirability of periodic calibration of instruments or the keeping of laboratory notes in a systematic way. What is disturbing is the fact that enormous amounts of time and effort may have to be expended to document routine activities of trivial significance, if present trends continue. The farther one moves from routine analytical services toward the research frontier, the less favorable the cost-benefit analysis of the GLP program becomes. For example, an instrument may be the center of a research objective, so its “calibration” in the routine sense is meaningless. T h e whole research effort may be considered to constitute a calibration of an analytical approach, with due priority being assigned to it,s most sensitive aspects. T h e probability of malfunction of the various component,s of an analysis syst,em varies from minuscule to overwhelming, and it is in the province of judgment of the research scientist to determine when the components need Calibration. It is wasteful to use the same intensity of effort on all aspects of all ana1,ytical operations. ANALYTICALCHEMISTRYplans to alert its readers to impending regulations as published in the Federal Register. The first contribution in this subject, area appears on page 975 A, this issue. We believe that it is in the best interest of the government agencies and the scientific community alike to stimulate the maximum possible participation of analytical chemists in the decision-making process.

The American Chemical Society and its editors assume no responsibility for the statements and opinions advanced by contributors Views expressed in the editorials are those of the editors and do not necessarily represent the official position of the American Chemical Society ANALYTICAL CHEMISTRY, VOL. 50, NO. 11, SEPTEMBER 1978

1409