By Willa; Patricia Royal and Francisca Liem (editors) Garner

ISBN-10: 0841217173

ISBN-13: 9780841217171

ISBN-10: 0841235996

ISBN-13: 9780841235991

content material: foreign alternate agreements and their influence on future health and environmental criteria and caliber coverage of information / Irving L. Fuller --
foreign harmonization through ISO / Peter Spath --
Laboratory competence : ISO consultant 25 or GLP? / John Gilmour and Helen Liddy --
The OECD GLP ideas and ISO/IEC consultant 25 : schisms and bridges / Theo Helder --
The effect of excellent laboratory perform accreditation courses on laboratory operation / Patricia Royal --
3rd occasion laboratory accreditation : A2LA, a case examine / Roxanne M. Robinson --
Laboratory accreditation lower than the nationwide environmental laboratory accreditation software for laboratories and box websites accomplishing GLP experiences within the usa : an replace / William W. John --
strong laboratory perform laws of the U.S. Environmental safety company : our challenge : earlier, current, and destiny / Francisca Liem and Mark J. Lehr --
Proposed adjustments in FIFRA GLPS : effect at the agricultural / William J. Litchfield --
contemporary revision to the U.S. Environmental safeguard business enterprise residue chemistry suggestions / Christine L. Olinger --
the results of the harmonization of regulatory requisites at the crop security / Frederick L. Groya --
Implementation of the meals caliber safety Act of 1996 / Margaret J. Stasikowski and Kathleen A. Martin --
effect of the nutrients caliber safety Act on : a demonstration utilizing case stories / C. Barrow, B. Shurdut, and D. Eisenbrandt --
The meals caliber safeguard Act of 1996 : an standpoint / Mark W. Galley --
strong laboratory practices and pesticide legislation in Mexico / Amada Velez --
insecticides registration method in Mexico / J.P. Serres, J. Morgado, and G. Salas --
Environmental evaluation of insecticides in Brazil / G.S.J. Dubois, D.A. do Carmo, M. Zerbetto, and E.R. dos Santos --
Brazilian and South American pesticide registration : the economic viewpoint / Thaïs Reis Machado --
prestige of insecticides keep an eye on in Cordoba, Argentina / Mirtha Nassetta and Sara Palacios --
overseas multi-country box experiences : GLP difficulties and ideas / Markus M. Jensen --
box trials in Latin the US : se habla GLP? / Steve West --
The Canadian pesticide registration approach within the context of overseas harmonization / Daniel Chaput --
caliber insurance for environmental laboratories in Canada / Richard Turle, Neil McQuaker, and Rick Wilson --
Registration techniques for agrochemicals within the eu Union / Jorge-I. Celorio --
GLP within the ecu Union : laws, implementation, and reports / Jutta Lange and Jorge-I. Celorio --
Registration in France : a altering scene : GLP certification : 2 performs in a single / Dominique Ambrosi and Christine Touratier --
GLP issues at the street to mutual acceptability : a Swiss viewpoint / Iris R. Wüthrich --
Ecotoxicology and stable laboratory perform : ecu requisites and practices / Nigel J. Dent --
Registration of plant security items : comparability of the U.S. and european types / Héctor F. Galicia and Ronald J. Breteler --
reliable laboratory practices and pesticide legislation in Japan / Fumihiko Ichinohe --
GLP nationwide prestige and amenities in India for pesticide product registration / B. Vasantharaj David --
Validation of entire GC and HPLC structures in analytical chemistry : is validation of person process parts fairly invaluable? / Michael Williams --
Validation, verification : risk, likelihood / Richard E. Cooney.

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Extra info for International Pesticide Product Registration Requirements. The Road to Harmonization

Sample text

3) ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems - General requirements for operation and recognition, International Organization for Standardization/International Electrotechnical Commission, Geneva, Switzerland. (4) ISO 9001:1994, Quality systems - Model for quality assurance in design, development, production, installation and servicing, International Organization for Standardization, Geneva, Switzerland. (5) ISO 9002:1994, Quality systems - Model for quality assurance in production, installation and servicing, International Organization for Standardization, Geneva, Switzerland.

As long as all GLP requirements are fulfilled. The OECD GLP Panel, consisting of the heads of all monitoring units of the OECD Member Countries, has considered also the use of laboratory accreditation with reference to GLP monitoring and has issued a position paper (4), stating that "data, generated solely under ISO/EEC Guide 25 or equivalent standards is unlikely to be accepted by regulatory authorities ". Simultaneous Implementation of GLP and ISO 25 The fact that ISO 25 and GLP are not equivalent does not mean that simultaneous implementation of both systems is impossible.

Monitoring and Surveillance According to Annex I to the OECD Council Decision, monitoring of GLP compliance has to be carried out by or on behalf of the governments of the OECD Member countries. This is understandable since governments are responsible for the admission of chemicals on their markets. Most governments have charged governmental or government-related bodies with this task. In some countries these bodies also have been charged with the task of laboratory accreditation, like in Australia (NATA), Ireland (ICLAB), New Zealand (Telarc) and Norway (NMS).

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International Pesticide Product Registration Requirements. The Road to Harmonization by Willa; Patricia Royal and Francisca Liem (editors) Garner


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