6/19/2015 GLP: GOOD LABORATORY Good Laboratory Practices PRACTICE � Definition : GLP embodies a set of principles that Ephy Khaemba provides a framework within which laboratory studies are planned performed, monitored, EOHS / RESEARCH reported and archived. COMPLIANCE � GLP is sometimes confused with the standards of MANAGER - ILRI laboratory safety like wearing safety goggles. HISTORY WHY WAS GLP CREATED? � GLP is a formal regulation that was created by the In the early 70’s FDA became � FDA (United states food and drug administration) in aware of cases of poor laboratory practice all over the United States. 1978. � FDA decided to do an in-depth � Although GLP originated in the United States , it had investigation on 40 toxicology a world wide impact. labs. � They discovered a lot fraudulent � Non-US companies that wanted to do business with activities and a lot of poor lab the United states or register their pharmacies in the practices. United States had to comply with the United States Examples of some of these poor � lab practices found were GLP regulations. Equipment not been calibrated to 1. � They eventually started making GLP regulations in standard form , therefore giving their home countries. wrong measurements. Incorrect/inaccurate accounts of � In 1981 an organization named OECD (organization 2. the actual lab study for economic co-operation and development ) Inadequate test systems 3. produced GLP principles that are international standard. FAMOUS EXAMPLE One of the labs that went � OECD Principles of GLP under such an investigation made headline news. The name of the Lab was � Industrial Bio Test. This was a � Define and describe a quality system concerned big lab that ran tests for big with the organisational processes and conditions companies such as Procter and under which a non-clinical health and Gamble. environmental safety study is conducted It was discovered that mice � that they had used to test cosmetics such as lotion and � Non-clinical laboratory study means in vivo or in deodorants had developed vitro experiments in which test articles are cancer and died. studied prospectively in test systems under Industrial Bio Test lab threw � the dead mice and covered laboratory conditions to determine their safety results deeming the products good for human consumption. Those involved in production, � distribution and sales for the lab eventually served jail time. 1
6/19/2015 Fundamental points of GLP GLP in the OECD Principles Good Laboratory Practice applied in whatever industry targeted, stresses the importance of the following main points � ‘ a quality system concerned with the � Resources : Organisation, personnel, facilities, organisational process and the conditions under equipment which non-clinical health and environmental � Rules : Protocols, Standard Operating Procedures, studies are planned, performed, monitored, recorded, archived and reported .’ concept of Study Director � Characterisation : Test items, test systems � I t does not concern with the technical validity of � Documentation : Raw data, final report, archives the studies � Quality Assurance : I ndependence from study conduct OBJECTIVES OF GLP Resources � GLP makes sure that the data submitted � Organisation and personnel are a true reflection of the results that are � Facilities and equipment obtained during the study. � GLP also makes sure that data is traceable. � Promotes international acceptance of tests. MISSION OF GLP GLP principles 1. Organization and Personnel � Test systems 2. Quality assurance program � Archiving of records and materials. 3. Facilities � Apparatus, material and reagent facilities. 4. Equipment, reagents and Materials � Quality assurance programs. 5. Test systems � Performance of the study. 6. Test & Reference items � Reporting of study results. 7. Standard operating procedures � Standard operating procedures (SOP) 8. Performance of Study 9. Reporting of results � Personnel and test facility organization 10. Storage of Records and Reports 2
6/19/2015 Standard Operating Procedures (SOP) SOP � Written procedures for a laboratories program. � Routine inspection, cleaning, maintenance, testing and calibration. � They define how to carry out protocol- � Actions to be taken in response to specified activities. equipment failure. � Most often written in a chronological � Analytical methods listing of action steps. � Definition of raw data � They are written to explain how the � Keeping records, reporting, storage, procedures are suppose to work mixing, and retrieval of data Statistical Procedures for Data Instrumentation Validation Evaluation � This is a process necessary for any � Statistical procedures are not simply analytical laboratory. chosen from a text book � Data produced by “faulty” instruments � Practitioners in a particular field may may give the appearance of valid data. adopt certain standards which are deemed � The frequency for calibration, re-validation acceptable within that field. and testing depends on the instrument � Regulatory agencies often describe and extent of its use in the laboratory. acceptable statistical procedures. � Whenever an instrument’s performance is outside the “control limits” reports must be discontinued Reagent/ Materials Certification Instrument Validation (cont) � Equipment records should include: � This policy is to assure that reagents used � Name of the equipment and manufacturer are specified in the standard operating procedure. � Model or type for identification � Serial number � Date equipment was received in the � Purchasing and testing should be handled laboratory by a quality assurance program. � Copy of manufacturers operating instruction (s) 3
6/19/2015 Reagents and Solutions cont Analyst Certification � Requirements: � Some acceptable proof of satisfactory training and/or competence with specific � Reagents and solutions shall be labeled laboratory procedures must be established � Deteriorated or outdated reagents and for each analyst. solutions shall not be used � Qualification can come from education, � Include Date opened experience or additional trainings, but it � Stored under ambient temperature should be documented � Expiration date � Sufficient people � Requirements of certification vary Laboratory Certification Specimen/Sample Tracking � Vary among laboratories � Normally done by an external agency � Evaluation is concerned with issues such as � Must maintain the unmistakable connection between a set of analytical � Adequate space data and the specimen and/or samples � Ventilation from which they were obtained. � Storage � Original source of specimen/sample (s) � Hygiene must be recorded and unmistakably connected with the set of analytical data. Important questions to be answered for any Documentation and Maintenance of analytical instrument Records � What is the equipment being used for? � Maintenance of all records provide documentation which may be required in the � Is the instrument within specification and is the event of legal challenges due to repercussions of documentation to prove this available? decisions based on the original analytical results. � General guidelines followed in regulated � If the instrument is not within specifications, how much does it deviate by? laboratories is to maintain records for at least five years � Length of time over which laboratory records � If the instrument is not within specifications what action has been taken to overcome the defect? should be maintained will vary with the situation � Can the standards used to test and calibrate the instrument be traced back to national standards? 4
6/19/2015 GLP compliance References � OECD Principles of basic GLP document GLP � http://www.sjsu.edu/faculty/chem55/55gl facility claim to be pout.htm � Each country has a compliant with OECD national GLP Principle of GLP must � http://www.labcompliance.com/tutorial/gl compliance be by NATA/ NPCB monitoring authority p/default.aspx?sm= d_a � UGA Office of the Vice President for � Registration To principles of GLP Research Authorities looks for � Wikipedia compliance 5
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