Good laboratory practice standards regulations

Final Rule for Good Laboratory Practice Standards under the Federal Insecticide, Fungicide and Rodenticide Act, Code of Federal Regulations, Title 40, Part 160. 

U.S. Environmental protection agency CFR—Code of Federal Regulations Title 40—Protection of Environment PART 792—Good laboratory practice standards, http //www.access.gpo.gov/ nara/cfr/waisidx 07/40cfr792 07.html... 

Good Laboratory Practice Standards (FIFRA), EPA. Eederal Register 1993, Title 40, Part 160, Code of Eederal Regulations, Einal Rule revised as of July 1. 

This study was exploratory and was not conducted in compliance with all Good Laboratory Practices (GLP) regulations however, GLP regulations were closely followed to the extent possible. Relevant Standard Operating Procedures (SOPs) were followed. 

Good Laboratory Practice Standards 40 Code of Federal Regulations Part 160 and... 

F1FRA Good Laboratory Practice Standards. Code of Federal Regulations, Section 160, Title 40, l982 Fed. Regist. 1983, 48, 53946 ff. 

Many of the measurements involved in corrosion tests are defined in standards to establish precision, accuracy, representativeness, and comparability [10-14], Analytical techniques and measurements used to characterize the environment and corrosion product chemistry, and to evaluate coatings properties and inhibitor performance, are largely covered by good laboratory practices" standards [45]. In addition, the requirements for certain analytical and environmental measurements used in regulatory efforts have been established in the Code of Federal Regulations (CFR) [47]. The corrosionist should become familiar with and use these sources of information as they apply to the goals and objectives of the study. Table 5 lists some of the ASTM standards that are more widely used by corrosionists. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

GLP stands for good laboratory practices. These are federal regulations governing FDA- and EPA-affiliated laboratories and pertain to proper procedures in the laboratory to ensure that results are obtained in as trustworthy a manner as possible. SOP stands for standard operating procedure. These are step-by-step written procedures that are specially approved by laboratory directors for carrying out certain specific tasks. 

This third edition of Good Laboratory Practice Regulations reflects that evolutionary maturity of requirements. With a relative uniformity of interpretation more specific and applied information can be provided, furnishing the reader with both the theoretical overview necessary to anticipate new and emerging interpretations and the detail of practical information that can serve as a guide to the current standards and requirements of good laboratory management. 

Good Laboratory Practice 58.105(a) requires that all test articles be appropriately characterized. Compliance requires documentation that characterization has been done. The tests conducted to provide this documentation, however, are not GLP-regulated, although such tests wiU in many instances be subject to CGMP standards (e.g., when the test article will also be used in human clinical studies). 

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