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Page 1: GLP: GOOD LABORATORY PRCATICE. - Kennesaw …ksuweb.kennesaw.edu/~jhendrix/regs/GLP… · PPT file · Web view · 2008-09-19Good Laboratory Practices Lori Gladney Izabella Osakwe

Good Laboratory Good Laboratory PracticesPractices

Lori GladneyLori Gladney Izabella OsakweIzabella Osakwe Endia FordEndia Ford

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GLP: GOOD LABORATORY GLP: GOOD LABORATORY PRACTICEPRACTICE

GLP GLP is an FDA regulation.is an FDA regulation. DefinitionDefinition: GLP embodies : GLP embodies

a set of principles that a set of principles that provides a framework provides a framework within which laboratory within which laboratory studies are planned studies are planned performed, monitored, performed, monitored, reported and archived.reported and archived.

GLP is sometimes confused GLP is sometimes confused with the standards of with the standards of laboratory safety like laboratory safety like wearing safety goggles.wearing safety goggles.

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HISTORYHISTORY GLP is a formal regulation that was created by the FDA GLP is a formal regulation that was created by the FDA

(United states food and drug administration) in 1978.(United states food and drug administration) in 1978. Although GLP originated in the United States , it had a world Although GLP originated in the United States , it had a world

wide impact.wide impact. Non-US companies that wanted to do business with the Non-US companies that wanted to do business with the

United states or register their pharmacies in the United United states or register their pharmacies in the United States had to comply with the United States GLP States had to comply with the United States GLP regulations.regulations.

They eventually started making GLP regulations in their They eventually started making GLP regulations in their home countries.home countries.

In 1981 an organization named OECD (organization for In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP economic co-operation and development ) produced GLP principles that are international standard.principles that are international standard.

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WHY WAS GLP CREATED?WHY WAS GLP CREATED? In the early 70’s FDA became In the early 70’s FDA became

aware of cases of poor aware of cases of poor laboratory practice all over laboratory practice all over the United States.the United States.

FDA decided to do an in-depth FDA decided to do an in-depth investigation on 40 toxicology investigation on 40 toxicology labs.labs.

They discovered a lot They discovered a lot fraudulent activities and a lot fraudulent activities and a lot of poor lab practices.of poor lab practices.

Examples of some of these Examples of some of these poor lab practices found were poor lab practices found were

1.1. Equipment not been Equipment not been calibrated to standard form , calibrated to standard form , therefore giving wrong therefore giving wrong measurements.measurements.

2.2. Incorrect/inaccurate accounts Incorrect/inaccurate accounts of the actual lab studyof the actual lab study

3.3. Inadequate test systemsInadequate test systems

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FAMOUS EXAMPLEFAMOUS EXAMPLE One of the labs that went One of the labs that went

under such an investigation under such an investigation made headline news.made headline news.

The name of the Lab was The name of the Lab was Industrial Bio Test. This was a Industrial Bio Test. This was a big lab that ran tests for big big lab that ran tests for big companies such as Procter companies such as Procter and Gamble.and Gamble.

It was discovered that mice It was discovered that mice that they had used to test that they had used to test cosmetics such as lotion and cosmetics such as lotion and deodorants had developed deodorants had developed cancer and died.cancer and died.

Industrial Bio Test lab threw Industrial Bio Test lab threw the dead mice and covered the dead mice and covered results deeming the products results deeming the products good for human consumption.good for human consumption.

Those involved in production, Those involved in production, distribution and sales for the distribution and sales for the lab eventually served jail time.lab eventually served jail time.

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OBJECTIVES OF GLPOBJECTIVES OF GLP GLP makes sure that the data GLP makes sure that the data

submitted are a true reflection of the submitted are a true reflection of the results that are obtained during the results that are obtained during the study.study.

GLP also makes sure that data is GLP also makes sure that data is traceable.traceable.

Promotes international acceptance of Promotes international acceptance of tests.tests.

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MISSION OF GLPMISSION OF GLP Test systemsTest systems Archiving of records and materials.Archiving of records and materials. Apparatus, material and reagent facilities.Apparatus, material and reagent facilities. Quality assurance programs.Quality assurance programs. Performance of the study.Performance of the study. Reporting of study results.Reporting of study results. Standard operating procedures (SOP)Standard operating procedures (SOP) Personnel and test facility organizationPersonnel and test facility organization

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Standard Operating Procedures Standard Operating Procedures (SOP)(SOP)

Written procedures for a laboratories Written procedures for a laboratories program.program.

They define how to carry out They define how to carry out protocol-specified activities.protocol-specified activities.

Most often written in a chronological Most often written in a chronological listing of action steps.listing of action steps.

They are written to explain how the They are written to explain how the procedures are suppose to workprocedures are suppose to work

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SOPSOP Routine inspection, cleaning, Routine inspection, cleaning,

maintenance, testing and calibration.maintenance, testing and calibration. Actions to be taken in response to Actions to be taken in response to

equipment failure.equipment failure. Analytical methodsAnalytical methods Definition of raw dataDefinition of raw data Keeping records, reporting, storage, Keeping records, reporting, storage,

mixing, and retrieval of datamixing, and retrieval of data

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Statistical Procedures for Data Statistical Procedures for Data EvaluationEvaluation

Statistical procedures are not simply Statistical procedures are not simply chosen from a text bookchosen from a text book

Practitioners in a particular field may Practitioners in a particular field may adopt certain standards which are adopt certain standards which are deemed acceptable within that field.deemed acceptable within that field.

Regulatory agencies often describe Regulatory agencies often describe acceptable statistical procedures.acceptable statistical procedures.

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Instrumentation ValidationInstrumentation Validation This is a process necessary for any This is a process necessary for any

analytical laboratory.analytical laboratory. Data produced by “faulty” instruments Data produced by “faulty” instruments

may give the appearance of valid data.may give the appearance of valid data. The frequency for calibration, re-The frequency for calibration, re-

validation and testing depends on the validation and testing depends on the instrument and extent of its use in the instrument and extent of its use in the laboratory.laboratory.

Whenever an instrument’s performance Whenever an instrument’s performance is outside the “control limits” reports is outside the “control limits” reports must be discontinued must be discontinued

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Instrument Validation (cont)Instrument Validation (cont)

Equipment records should include:Equipment records should include: Name of the equipment and Name of the equipment and

manufacturermanufacturer Model or type for identificationModel or type for identification Serial numberSerial number Date equipment was received in the Date equipment was received in the

laboratorylaboratory Copy of manufacturers operating Copy of manufacturers operating

instruction (s)instruction (s)

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Reagent/ Materials Reagent/ Materials CertificationCertification

This policy is to assure that reagents This policy is to assure that reagents used are specified in the standard used are specified in the standard operating procedure.operating procedure.

Purchasing and testing should be Purchasing and testing should be handled by a quality assurance handled by a quality assurance program.program.

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Reagents and Solutions contReagents and Solutions cont

Requirements:Requirements: Reagents and solutions shall be labeled Reagents and solutions shall be labeled Deteriorated or outdated reagents and Deteriorated or outdated reagents and

solutions shall not be usedsolutions shall not be used Include Date openedInclude Date opened Stored under ambient temperatureStored under ambient temperature Expiration dateExpiration date

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Analyst CertificationAnalyst Certification Some acceptable proof of satisfactory Some acceptable proof of satisfactory

training and/or competence with specific training and/or competence with specific laboratory procedures must be established laboratory procedures must be established for each analyst.for each analyst.

Qualification can come from education, Qualification can come from education, experience or additional trainings, but it experience or additional trainings, but it should be documentedshould be documented

Sufficient peopleSufficient people Requirements of certification varyRequirements of certification vary

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Laboratory CertificationLaboratory Certification Normally done by an external agencyNormally done by an external agency Evaluation is concerned with issues such Evaluation is concerned with issues such

as as Adequate spaceAdequate space VentilationVentilation StorageStorage HygieneHygiene

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Specimen/Sample TrackingSpecimen/Sample Tracking Vary among laboratoriesVary among laboratories Must maintain the unmistakable Must maintain the unmistakable

connection between a set of analytical connection between a set of analytical data and the specimen and/or samples data and the specimen and/or samples from which they were obtained.from which they were obtained.

Original source of specimen/sample (s) Original source of specimen/sample (s) must be recorded and unmistakably must be recorded and unmistakably connected with the set of analytical connected with the set of analytical data.data.

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Documentation and Documentation and Maintenance of RecordsMaintenance of Records

Maintenance of all records provide Maintenance of all records provide documentation which may be required in the documentation which may be required in the event of legal challenges due to repercussions event of legal challenges due to repercussions of decisions based on the original analytical of decisions based on the original analytical results.results.

General guidelines followed in regulated General guidelines followed in regulated laboratories is to maintain records for at least laboratories is to maintain records for at least five yearsfive years

Length of time over which laboratory records Length of time over which laboratory records should be maintained will vary with the should be maintained will vary with the situationsituation

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Important questions to be answered Important questions to be answered for any analytical instrumentfor any analytical instrument

What is the equipment being used for?What is the equipment being used for?

Is the instrument within specification and is the Is the instrument within specification and is the documentation to prove this available?documentation to prove this available?

If the instrument is not within specifications, how If the instrument is not within specifications, how much does it deviate by?much does it deviate by?

If the instrument is not within specifications what If the instrument is not within specifications what action has been taken to overcome the defect?action has been taken to overcome the defect?

Can the standards used to test and calibrate the Can the standards used to test and calibrate the instrument be traced back to national standards?instrument be traced back to national standards?

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What happens if a What happens if a workplace does not comply workplace does not comply

with federal Good with federal Good Laboratory Practice Laboratory Practice

standards?standards?

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Disqualification of a Facility Disqualification of a Facility Before a workplace can experience Before a workplace can experience

the consequences of noncompliance, the consequences of noncompliance, an explanation of disqualification is an explanation of disqualification is neededneeded

The FDA states the purpose of The FDA states the purpose of disqualification as the exclusion of a disqualification as the exclusion of a testing facility from completing testing facility from completing laboratory studies or starting any laboratory studies or starting any new studies due to not following the new studies due to not following the standards of compliance set by the standards of compliance set by the Good Laboratory Practice manual Good Laboratory Practice manual

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Possible ViolationsPossible Violations Falsifying information for permit, Falsifying information for permit,

registration or any required recordsregistration or any required records Falsifying information related to Falsifying information related to

testing~ protocols, ingredients, testing~ protocols, ingredients, observations, data equipment, ect.observations, data equipment, ect.

Failure to prepare, retain, or submit Failure to prepare, retain, or submit written records required by lawwritten records required by law

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Grounds for DisqualificationGrounds for Disqualification The testing facility failed to comply The testing facility failed to comply

with one or more regulations with one or more regulations implemented by the GLP manualimplemented by the GLP manual

The failure to comply led to adverse The failure to comply led to adverse outcomes in the data; in other words, outcomes in the data; in other words, it affected the validity of the studyit affected the validity of the study

Warnings or rejection of previous Warnings or rejection of previous studies have not been adequate to studies have not been adequate to improve the facility’s complianceimprove the facility’s compliance

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Consequences of Consequences of NoncomplianceNoncompliance

The FDA states the following consequences of The FDA states the following consequences of noncompliance:noncompliance: The commissioner will send a written proposal of The commissioner will send a written proposal of

disqualification to the testing facilitydisqualification to the testing facility A regulatory hearing on the disqualification will be A regulatory hearing on the disqualification will be

scheduledscheduled If the commissioner finds that after the hearing, If the commissioner finds that after the hearing,

the facility has complied, then a written the facility has complied, then a written statement with an explanation of termination of statement with an explanation of termination of disqualification will be sent to the facilitydisqualification will be sent to the facility

Thus, if it can be shown that such disqualifications Thus, if it can be shown that such disqualifications did not affect the integrity and outcome of the did not affect the integrity and outcome of the study itself, or did not occur at all, then the study study itself, or did not occur at all, then the study may be reinstated at the will of the commissionermay be reinstated at the will of the commissioner

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Upon Disqualification…Upon Disqualification…If the commissioner finds that the facility was If the commissioner finds that the facility was

noncompliant on any of the grounds after the noncompliant on any of the grounds after the hearing, then a final order of noncompliance hearing, then a final order of noncompliance will be sent to the facility with explanations will be sent to the facility with explanations

If a testing facility has been disqualified, any If a testing facility has been disqualified, any studies done before of after the disqualification studies done before of after the disqualification will need to be determined as essential to a will need to be determined as essential to a decision (acceptable or not)decision (acceptable or not)

If the study is determined unacceptable, then the If the study is determined unacceptable, then the facility itself may need to show that the study facility itself may need to show that the study was not affected by the noncompliance that led was not affected by the noncompliance that led to the disqualificationto the disqualification

Once finally disqualified, the facility may not Once finally disqualified, the facility may not receive or be considered for a research or receive or be considered for a research or marketing permit and the study is rejected.marketing permit and the study is rejected.

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Upon Disqualification…Upon Disqualification… The commissioner may notify the public and all The commissioner may notify the public and all

interested persons, including other federal interested persons, including other federal agencies the facility may have contactedagencies the facility may have contacted

The FDA may ask the other agencies to consider The FDA may ask the other agencies to consider whether to support the facility or not under the whether to support the facility or not under the disqualificationdisqualification

Civil or criminal proceedings may occur at the Civil or criminal proceedings may occur at the discretion of the commissionerdiscretion of the commissioner Fines of up to $50,000 if one knowingly commits crime Fines of up to $50,000 if one knowingly commits crime

and/or 1 year imprisonment~ for registration and/or 1 year imprisonment~ for registration applicants and producersapplicants and producers

Fines up to $5,000 all others~ civil penalty after failing Fines up to $5,000 all others~ civil penalty after failing to improve after a minor violation warning was to improve after a minor violation warning was issued~ only those involved in testing will be given issued~ only those involved in testing will be given civil penaltiescivil penalties

Those involved in the distribution or sales will be Those involved in the distribution or sales will be assessed more heavy penalties, such as criminal assessed more heavy penalties, such as criminal penaltiespenalties

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Upon Disqualification…Upon Disqualification… The FDA may turn it over to the The FDA may turn it over to the

federal, state or local law enforcementfederal, state or local law enforcement The facility’s sponsor may terminate or The facility’s sponsor may terminate or

suspend the facility from doing any suspend the facility from doing any non- clinical study for a permitnon- clinical study for a permit

The sponsor is required to notify the The sponsor is required to notify the FDA in writing within 15 working days FDA in writing within 15 working days that the facility is to be suspended or that the facility is to be suspended or terminated and whyterminated and why

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Reinstatement of a Disqualified Reinstatement of a Disqualified FacilityFacility

The testing facility may be reinstated as The testing facility may be reinstated as acceptable non-clinical study to be turned into acceptable non-clinical study to be turned into the FDA if the commissioner can be certain the FDA if the commissioner can be certain that future studies will be conducted in that future studies will be conducted in compliance with the Good Laboratory Practice compliance with the Good Laboratory Practice standards and that any current studies standards and that any current studies integrity have not been severely harmed by integrity have not been severely harmed by the disqualificationthe disqualification

The disqualified facility will be required to put The disqualified facility will be required to put in writing to the commissioner reasons why it in writing to the commissioner reasons why it should be reinstated and any actions the should be reinstated and any actions the facility will take or have taken to assure any facility will take or have taken to assure any disqualification problems will not happen againdisqualification problems will not happen again

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Reinstatement of a Disqualified Reinstatement of a Disqualified FacilityFacility

The commissioner will inspect the The commissioner will inspect the facility and determine if it shall be facility and determine if it shall be reinstatedreinstated

If it is reinstated, the commissioner is If it is reinstated, the commissioner is required to notify all persons that required to notify all persons that were notified of the disqualification were notified of the disqualification including the facility itself including the facility itself

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ReferencesReferences http://www.sjsu.edu/faculty/chem55/http://www.sjsu.edu/faculty/chem55/

55glpout.htm55glpout.htm http://www.labcompliance.com/tutorihttp://www.labcompliance.com/tutori

al/glp/default.aspx?sm=d_aal/glp/default.aspx?sm=d_a UGA Office of the Vice President for UGA Office of the Vice President for

ResearchResearch WikipediaWikipedia


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