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CHMB16FALL 2012 Lecture 2

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Kagan Kerman

CHMB16Fall2012 Lecture 2: GLP (Good Laboratory Practice) – Chapter 1 o GLP is an FDA regulation o GLP: embodies a set of principles that provides a framework within which lab studies are planned, performed, monitored, reported and achieved o GLP is confused with lab safety like wearing goggles and lab coats History o GLP is a formal regulation that was created by the FDA in 1978 o Used world-wide now, started in the U.S.A o In 1981, OECD (organization for economic co-operation and development ) produced GLP principles that are international standard Why was GLP created? o in early 70’s the FDA became aware of poor lab practice all over the U.S.A o investigated 40 toxicology labs and found fraudulent activities and a lot of poor lab practices o examples: equipment was not calibrated to standard form so was giving wrong measurements, incorrect or inaccurate account of the actual lab study (false results were reported) and inadequate test systems Famous example: o name of lab was Industrial Bio Test  ran rat tests for big companies like Procter and Gamble o discovered that mice that their cosmetics were tested on developed cancer and died , but the lab threw those rats away and deemed the products good for human consumption o those involved in production, distribution and sales for the lab eventually served jail time Objectives of GLP o GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study o Makes sure data is traceable o Promotes international acceptance of tests Mission of GLP o Test systems o Archiving of records and materials o Apparatus, material and reagent facilities o QA programs o Performance of the study o Reporting study results o Standard operating procedures (SOP) o Personnel and test facility organization Standard Operating Procedures (SOP) o Written procedures for a lab program o Define how to carry out protocol specified activities o Most often written in chronological listing of action steps o They are written to explain how the procedures are supposed to work o Routine inspection, cleaning and maintenance, testing and calibration o Actions to be taken in response to equipment failure o Analytical methods 1 o Definition of raw data o Keeping records, reporting, storage, mixing and retrieval of data Statistical Procedures for Data Evaluation o Practitioners in a particular field may adopt certain standards which are deemed acceptable within their field  statistical procedures are not just chosen from a textbook o Regulatory agencies often describe acceptable statistical procedures Instrument validation o Data produced by “faulty” instruments may give the appearance of valid data o The frequency of calibration, re-validation and testing depends on the instrument and extent of its use in the laboratory o Whenever an instrument’s performance is outside the control limits, reports must be discontinued o Equipment records should include: name of the equipment and manufacturer, model or type for ID, serial number, date equipment was received in the lab o Copy of manufacturer’s operating instructions Reagent/Materials Certification o This policy is to assure that reagents used are specified in the standard operating procedure o Purchasing and testing should be handled by a quality assurance program o Requirments: reagents and solutions have to be labeled, deterioration or outdated reagents and solutions shall not be used, include Data opened, stored under ambient temperature, expiration date Analyst certification o Acceptable proof of satisfactory training and/or competence with specific lab procedures must be established for each analyst o Qualification can come from education, experience or additional trainings, but should be documented o Sufficient people o Requirements of certification vary Lab certification o Done by external agency o Evaluation is concerned with issues such as: adequate space, ventilation, storage and hygiene Specimen/Sample Tracking o Must maintain unmistakable connection between a set of analytical data and the specimen and/or samples from which they were obtained o Original source of specimen/sample must be recorded and unmistakably connected with the set of analytical data Documentation and Maintenance of records o Maintenance of all records provide documentation which may be required in the event of legal challenges due to repercussions of decisions based on the original analytical results o General guidelines followed in regulated labs is to maintain records for at leas
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