lec05.qa_qc - Click to edit Master subtitle style Quality...

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Click to edit Master subtitle style /2/11 Quality Assurance &
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/2/11 Quality Assurance Quality Control A planned set of activities necessary to provide adequate confidence that requirements are properly established and products or service conform to specified requirements. Sets up measurement programs to evaluate processes. Identifies weakness in process and improves them. The process by which product quality is compared with applicable standards; and the action taken when nonconformance detected. An activity which verifies that the process meets pre- defined standards.
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/2/11 The Objectives of a Quality Assurance/Quality Control Program To document the procedures and methods of sample collection, preparation and analysis. To provide assurance as to reliability of analyses using replicate samples, cross-laboratory checks and an “known reference” standards. To provide assurance as to the precision from duplicate samples. To provide assurance as to the accuracy from using recognized reference standards. To provide reliable information regarding the interpretation of the data. To provide a chain of custody of samples. Bruce W. Downing, M.Sc., P.Geo . is Senior Geologist, Gamah International Ltd., Vancouver .
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/2/11 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES 21 CFR PART 58 - Food and Drug Administration 40 CFR PART 160 – Environmental Protection Agency http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=68585f39e9accd101eb9a716f01fc95e&rgn=div5&view=text&nod
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/2/11 GLP Principles…
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/2/11 Testing Facility (a) Must designate a study director. (b) Must have a quality assurance unit. “A testing facility shall permit an authorized employee of the Food and Drug Administration to inspect the facility and to inspect all records and specimens required to be maintained regarding the study.”
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/2/11 Facilities Each testing facility shall be of suitable size and construction and shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study. As necessary to prevent contamination or mixups, there shall be separate areas for: (1) Receipt and storage of the test and control articles. (2) Mixing of the test and control articles with a carrier, e.g., feed. (3) Storage of the test and control article
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lec05.qa_qc - Click to edit Master subtitle style Quality...

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