Good Laboratory Practice RegulationsSandy Weinberg This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references. |
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agency amendments analytical animals ANOP application appropriate archives areas audit compliance programs contaminants control articles DATAOP determine disqualification documentation Drug Administration drug applications Economic Behavior edited effective environmental equipment established evaluation FDA's Federal Insecticide Federal Register FIFRA final report food additives Food and Drug GALPS GLP compliance GLP inspection GLP principles GLP regulations GLP requirements GLP standards guidelines Health identified implementation informing process investigators issued Laboratory Practice Regulations MAFF Manufacturing Practices marketing permit master schedule materials Ministry mixtures MOHW monitoring nonclinical laboratory study Notification OECD performed personnel Pharmaceutical process confirmation proposed protocol quality assurance unit raw data records regulatory research or marketing Residue Chemistry responsibility robot Rodenticide safety sample SOPs specific specimens sponsor standard operating procedures storage study director submitted test and control test article test or control test system testing facility toxicity toxicology TSCA validation