GLP's and Regulations - Analytical Chemistry (ACS Publications)

May 25, 2012 - Romer A. Romero. Anal. Chem. , 1978, 50 (13), pp 1186A–1186A. DOI: 10.1021/ac50035a720. Publication Date: November 1978...
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Letters

GLP's and Regulations Sir: I really enjoyed Mr. Horwitz' arti­ cle entitled "Good Laboratory Prac­ tices in Analytical Chemistry," which appeared in the May 1978 issue. I dis­ cussed the article with my students in my analytical chemistry course a t the University of Zulia. My main purpose in doing this was to emphasize the needs and responsibilities of analytical chemists in our jobs. T h i s is a neces­ sary and valid idea to inculcate in new generations of chemists. Also, I have the opportunity, by using the illustrations, to lecture about safety (mainly on the need to wear eye protectors like goggles). I feel in our country we do not have enough safety rules for academic laboratory work. We are struggling t o elaborate and apply these rules to guarantee safety in the chemistry lab. Our peo­ ple still don't understand why safety glasses must be worn, why mouth pi­ petting must be avoided, or why chemicals must not be inhaled, touched, or tasted, regardless of what chemicals one is working with. I suggest you publish some articles on this topic, which I'm sure would be welcome in many countries around the world. Romer A. Romero Safety Committee Chairman Department of Chemistry University of Zulia Maracaibo, Venezuela Reply: We plan to have an article on laboratory safety early in 1979. Sir: In reference to your editorial on GLP's, analytical chemists might par­ ticipate in the decision-making pro­ cess if they knew what the decisions were about and how to participate. Few will have access to the document. I suggest t h a t you publish it in sec­ tions because it is too long for one

issue of ANALYTICAL

CHEMISTRY.

C o m m e n t upon the sections by some­ one familiar with FDA thinking would be helpful in revealing the meaning of the bureaucrateese and the location of potential booby traps. P a r t of GLP's is already in G M P ' s (good manufacturing practices), and some of it will undoubtedly be includ­

ed in future G?P's. Who is next? T h e clinical chemists? T h a t will be an in­ teresting encounter for the FDA law­ yers who concoct the regulations. Progressive chemistry departments will establish at least one course to teach chemists to read and under­ stand regulations. They will learn, what is to them, the peculiar thought process of lawyers and of other quali­ tative people who dominate govern­ ment. These people seem to think t h a t proceeding according to regulations and doing the paper work are all t h a t are necessary to achieve correct re­ sults. My suggestions are: print the G L P ' s in sections, solicit comment on each section, print section and comments together, and pay particular attention to comments from within the FDA concerning unstated nonscientific as­ pects of the document. Voluminous comments have been made and should be available to you. Should you decide to use existing ma­ terial, it should be selected very care­ fully by an experienced analyst (not a journalist) with the unofficial assis­ tance from someone from FDA. T h e reasons the G L P ' s were written are worth publishing. It is time t h a t ana­ lysts become aware of the politics of regulations and the p a r t analysts had in causing them to be written. A bit of the real world would not be out of

place in ANALYTICAL

CHEMISTRY.

Frederick K a v a n a g h 231 Blue Ridge Road Indianapolis, Ind. 46208 Reply: An ad hoc committee was ap­ pointed by the Analytical Chemistry Division of the American Chemical Society in September at Miami Beach to contribute material for publication in the REGULATIONS section of t h e JOURNAL. Robert A. Libby of Procter & Gamble is chairman of this commit­ tee, which also includes Donald T. Sawyer, University of California, Riv­ erside; William T. Donaldson, EPA; and Warren Crummett, Dow Chemical Co. This committee will be addressing some of the problems you raise in your letter. See Dec. REGULATIONS. T h e JOURNAL itself cannot spare the space for publication of the G L P ' s or other regulations as they are pub­ lished. Our pages are urgently needed

1186 A • ANALYTICAL CHEMISTRY, VOL. 50, NO. 13, NOVEMBER 1978

for publication of original research contributions. Many libraries sub­ scribe to the Federal Register. Sub­ scriptions to the Federal Register, which is published daily, M o n d a y - F r i ­ day, are available, postage free for $5.00 per month or $50 per year, paya­ ble in advance. Individual copies are 75φ for each group of bound pages. Send check or money order payable to the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Free workshops on how to use t h e Federal Register will be held in Nov. and D e c ; see For Your Information, page 1221· A, this issue.

Typo Noted Sir: We have recently noticed a typo­ graphical error in the "Side by Side Drinking Water Analysis H a n d b o o k " (published by Hach Chemical Co., Ames, Iowa, copyright 1977) t h a t could cause serious injury. On page 31 of this manual, under Arsenic deter­ mination, Note Ε recommends the re­ placement of the zinc slurry with a so­ dium borohydride solution. T h e pro­ cedure for preparing this solution as written recommends a 25% sodium bo­ rohydride solution instead of a 2.5% solution. T h e use of the 25% solution results in extremely vigorous genera­ tion of hydrogen accompanied by large pressure buildup. Because this manual may be used by water quality labs as a quick refer­ ence for lab technicians, we felt it ad­ visable to notify others of this poten­ tial safety hazard. William G. L e s e m a n City of Tallahassee Water Quality Lab City Hall Tallahassee, Fla. 32304

Contributions from readers are in­ vited for the LETTERS section. Topics should preferably be of broad interest to readers and/or may be comments on material pub­ lished in the A-pages. See Prof. Laitinen's editorial, page 1281, August 1977.