TECHNICAL GUIDANCE FOR THE

If the MPS system is introduced to a packing house, taste-oriented grading will become possible. If the quality data from the MPS system are correlated with data corresponding to cultivation conditions such as soil and weather, technical guidance for the production of high-quality products will also be realized. 

UKWIR (2000) Technical Guidance for the Implementation of Direct Toxicity Assessment (DTA) for Effluent Control Addressing Water Quality Problems in Catchments where Acute Toxicity is an Issue. Report TX02B 217. 

U.S. EPA-Region 1. Technical guidance for the natural attenuation indicators methane, ethane, and ethene. Methane, Ethane, Ethene Analysis Guidance, Revision 1, 2002. 

The first part of this section is an edited version of Appendix K of the Technical Guidance for Hazards Analysis. This appendix is entitled "Evaluation Guide for Available Computer Applications Addressing Emergency Response Planning". (EPA document)... 

Calculates the vulnerability zone based on the maximum quantity present for screening Calculations are based on credible worst case a.ssumptions identified in the Technical Guidance for Hazards Analvsis. 

Employs dispersion models that are consistent with those used in the Technical Guidance for Hazards Analysis ... 

The handbook additionally provides an extensive overview and comparison of commercially available computer systems and software for chemical emergency planning. This section provides technical guidance for hazard analysis and identification implementing regulatory requirements and descriptions of computer applications and systems applicable under SARA Title III. 

Guidance concerning the extent of testing required is also given in the Technical Guide for the elaboration of monographs (1996) of the European Pharmacopoeia. These guidelines are specifically addressed to the establishment of reference substances for pharmacopoeial use. 

The successful closure of JACADS will be a major accomplishment for the CSDP and will provide guidance for the closure of other chemical agent disposal facilities in the continental United States. This chapter examines a number of the technical considerations involved in planning for the closure. Issues related to the execution of a closure plan and postclosure activities are covered in Chapters 4 and 5. 

Guidance on the content of the Nonclinical Overview (NCO) is given in ICH M4S, Common Technical Document for the Registration of Pharmaceuticals for Human Use—Safety, CHMP/ ICH/2887/99 Rev 1 Safety. This guideline also gives information on the structure and content of the narrative and tabular summaries that contain the more detailed information. 

Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The international standard ISO/ IEC [1] requires validation of nonstandard methods, laboratory designed/devel-oped methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are suitable for their intended use. The Guidance on the Interpretation of the EN 45000 Series of Standards and ISO/IEC Guide 25 includes a chapter on the validation of methods [2] with a list of nine validation parameters. The International Conference on Harmonization (ICH) of Technical Requirements for the... 

International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures Definitions and Terminology. ICH-Q2A, Geneva (1995) (CPMP/ICH/ 381/95), Internet http //www.fda.gov/cder/guidance/ichq2a.pdf. 

A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1), which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications. 

Currently there is relatively little guidance for the use of QSARs to predict the toxicity and fate (especially in the environment) of chemicals. Some guidance is provided within the European Union (EU) where a comprehensive technical guidance document (TGD) was produced to support the Directive on New Substances and the Regulation on Existing Substances (European Economic Community, 1996). This document includes a substantial chapter providing guidance on the use of QSARs in environmental risk assessments. 

The European Union (EU), like the US EPA, supports the use of QSARs for screening new chemicals. The EU s Technical Guidance Document provides extensive guidance for the use of QSARs (see Further... 

Overall policy guidance for the work of IPCS is provided by the Programme Advisory Committee, which is composed of 20 external experts who serve as individuals, rather than representing their respective organizations. This committee provides advice on scientific, technical, ethical, administrative, and regulatory aspects of the activities of the IPCS. 

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