Nucleic Acid Analysis with UV-vis and NMR - Spectroscopy

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22 Spectroscopy 24(11) November 2009 www.spectroscopyonline.com and also instruments that operate in the lower reaches of the atmosphere. Interfaces will differ, of course, but the basic pumping needs within the instrument itself remain similar. Outside that range, design considerations diverge. (4) Granville-Phillips, Issues in Vacuum Measurement, “It’s a Myth that Less Accuracy is Needed for Low- Pressure Measurement.” Found at http://www.brooks.com/documents. cfm?documentID=4879. (5) K. Jousten, Handbook of Vacuum Technology (Wiley-VCH, New York, New York, 2008). (6) J.F. O’Hanlon, A User’s Guide to Vacuum Technology (John Wiley and Sons, Hoboken, New Jersey, 2003). (7) D.J. Hucknall and A. Morris, Vacuum Technology: Calculations in Chemistry, (Royal Society of Chemistry, UK, 2003). (8) A very useful compendium of vacuum technology references is found at: http://www.atomwave. org/rmparticle/ao%20refs/ aifm%20refs%20sorted%20by %20topic/beam%20detectors/ Vacuum%20References.doc. (9) S. Dittmann, “NIST Measurement Services: High Vacuum Standard and Use, 1989.” Found at http://ts.nist. gov/MeasurementServices/Calibrations/upload/SP250-34.pdf (10) J.H. Hendricks , P.J. Abbott, J.E. Ricker, J.H. Chow, and J.D. Kelley, “Development of a New NIST Calibration Service Using the Comparison Method for Vacuum Gauges Spanning the Range 0.65 Pa to 133 kPa,” found at www.cstl.nist.gov/projects/fy06/ indst0683608.pdf. (11) See http://www.vacuumlab.com/Articles/VacLab32.pdf. (12) See http://www.plasma.org/activity/ groups/subject/vac/Events_Archive/ file_8392.ppt. Kenneth L. Busch grew up in the era of belt-driven rough pumps. KLB always remembers to put a leak tray under his rough pumps, he knows what a sight glass is, and he knows the chemical molecular composition of many diffusion pump oils. In his youth, with a steadier hand, he could replace filaments in nude ionization gauges. Extra bonus points with no redeemable cash value are sent via email to those who deduce the pun not quite hidden in this column. No hints provided. Responsibility for this column resides solely with the author, who can be reached at: wyvernassoc@yahoo.com For more information on this topic, please visit: www.spectroscopyonline.com/busch
23 Spectroscopy 24(11) November 2009 www.spectroscopyonline.com Focus on Quality The Tiger Has Sharp New Teeth The new FDA Commissioner wants a strong FDA and is backing her words with action by initiating a program that cuts the time that firms must respond to 483 observations from 30 to 15 business days. Not only is the time halved but the response must be complete. Therefore it is better and cheaper to be compliant than not. R.D. McDowall The Food and Drug Administration (FDA) has not had good press over the last few years, as they have been on the receiving end of two critical reports from the Government Audit Office (GAO). The last report covered the FDA foreign inspection program and was damning in the fact that the FDA does not know how many establishments it has to inspect, relies upon volunteers to inspect overseas, and when they do conduct inspections, the frequency is lower than in the U.S. (1). FDA Modernization Act 2009 As a result of this report and also the increased threat of supply chain contamination, the FDA Modernization Act 2009 (2) is being passed into law and covers the following areas: • Creates an up-to-date registry of all drug and device facilities serving American consumers. • Increases funding for more GMP inspections for ethical and generic drugs as well as introduces preapproval inspections for generic drugs. • Requires parity between foreign and domestic inspections, and to meet this, the FDA is setting up offices in China, India, Europe, and Latin America. • Denies entry to drugs coming from facilities that limit, delay, or deny FDA inspections. • Requires manufacturers to know their supply chain including the identification and mitigation of risk throughout their supply chain. • Requires country-of-origin labeling for components. Concomitantly, there also has been an increase in budget to fund this and increase the inspection program. So what does that mean for me in the laboratory? This stuff appears to be too high a level to even contemplate doing anything about. What’s this about a tiger and new teeth? It may seem that the tiger has been stuffed but the good bits start in the next section. New FDA Commissioner Acts In addition to the FDA Modernization Act 2009, there also has been a change at the top with the appointment of Dr. Margaret Hamburg as the new FDA commissioner in May 2009. On August 6, 2009, the new commissioner made a speech that emphasized the need for a “strong FDA,” which highlighted the benefits of this new approach as having credibility with the public, being transparent in explaining its decisions, being able to enforce the law, and being creative in promoting health. In this speech, with an accompanying video (3), were such quotations as • “Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems early.” • “Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, we will.” • “The agency must show industry and consumers that we are on the job. We must publicize our enforcement actions — and the rationale for those actions — widely and effectively.”
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