Operations guidance documents

This previous definition had been broadened after the FDA s issue of the PAT guidance document to encompass aU factors influencing the quality and efficiency of a chemical or pharmaceutical manufacturing process. Driven by developments in Six-Sigma and operational excellence programs an extended definition included such items as ... 

OECD (2008) Environment, Health and Safety Publications Series on Testing and Assessment, No. 43. Guidance Document on Reproductive Toxicity Testing and Assessment. Environment Directorate, Organisation for Economic Co-operation and Development. http //www.oecd.org/ officialdocuments/ displaydocumentpdficote=env/jm/mono%2 8 2008%29168tdoclanguage=en. Accessed 12 Feb 2012... 

As the following discussion will show, implementation of source reduction, whatever is included in its definition, involves site-specific testing of possibilities which are often nothing more than good ideas. This chicken-and-egg dilemma is most obvious in the literature available to plating plant operators, where documentation is often limited to obvious successes and guidance to "try it, you ll like it "... 

This guidance document represents the Agency s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. 

Organisation for Economic Co-Operation and Development [OECD], 2001. Guidance document on the use of the harmonized system for the classification of chemicals which are hazardous for the aquatic environment. OECD Series on Testing and Assessment. No. 27 ENV/JM/MONO. Paris (France) Organization of Economic Cooperation and Development, 8 p. 

OECD] Organization for Economic Cooperation and Development. 2006b. Guidance document on simulated freshwater lentic field tests (outdoor microcosms and mesocosms). Paris (France) Environment Directorate, Organisation for Economic Co-operation and Development. Series on testing and assessment, no. 53, ENV/IM/ MONO(2006)17. 37 p. 

OECD (1997). Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, OECD Environmental Health and Safety Publications, Series on Testing and Assessment No. 9, OECD/GD(97)148, Organization for Economic Co-operation and Development, Paris, France. 

Considering the complexity of this endpoint and the breadth of the application of the system, the Guidance Documents are considered an important element in the operation of the harmonized scheme. (As noted above. Annex 10 is subject to validation.)... 

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