Good Laboratory Practice processing

All testing to support notification must be performed by methods specified in Annex V to Directive 79/831/EEC and in accordance with the principles of good laboratory practice (GLP). GLP is concerned with the organizational processes and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Good Laboratory Practice (GLP) regulations and their impact on the small-scale processing procedures... 

Note that good laboratory practice (glp) should not be confused with Good Laboratory Practice (GLP). The latter is the name given to a set of principles governing the organizational process and the condition under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported, and was put forward initially by the Organization for Economic Co-operation and Development (OECD) (see Chapters 2 and 9). 

Good Laboratory Practice (GLP) is a quaiity system concerned with the organizationsi process and the conditions under which a study is pianned, performed, monitored, recorded, archived and reported. 

Sections of the Redbook have been updated in phases in October 2001, November 2003, and April 2004, and the updating process is continuing. Alternative approaches can be used but should be discussed with the OFAS. All toxicological studies must be in compliance with Good Laboratory Practice regulations published in 21 CFR Part 58. 

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

On February 10 and 11 (1987, we) met in Geneva, New York and informally audited the Good Laboratory Practices (GLP s) and performed a Quality Assurance (QA) audit of. .. projects chosen at random. It was intended for the laboratory personnel to understand that the audit process would be helpful to their organization and also helpful to the. .. program. The entire staff of the Geneva labs participated in the process in a very cooperative and hospitable manner. 

Human specimens. In our laboratory, we first developed a good laboratory practice (GLP)-validated procedure for quantification of intact rafAON in control human plasma. The rafAON assay validation endpoints were standard curve, between-run precision and accuracy, within-run precision and accuracy, effects of dilution and freeze thaw, stability of rafAON at -80° C, and 4°C in plasma for various times, specificity, integrity of rafAON during plasma sample collection and processing, and lipid interference. The reader is referred to a previous citation for further details (17,27). 

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