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