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Introduction to good laboratory practices. For more, visit: http://www.ubio.in
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GOOD LABORATORY PRACTICE
Do, what you write
Write, what you do
•GLP goes hand-in-hand with QA (quality assurance)
•GLP without quality is useless
USA: FEDERAL DRUG ADMINISTRATION
1906: Food, Drug and Cosmetic Act FDA has to prove the poor quality for withdrawing a drug from the market
1938: Manufacturer has to effectiveness of a drug
1962: Manufacturer has to prove safety and effectiveness of ‘New Drugs’
USAFEDERAL DRUG ADMINISTRATION
1979:Good Laboratory Practice Regulations(Revised several times)
Other agencies had endorsed the conceptEg: Environmental Protection Agency (EPA)
•GLP is not an Act/Legislation/Statute
•GLP is a regulation/guideline
Code of Federal regulations(Food and Drug Administration) Part 58
•Good Laboratory practice for non-clinicalLaboratory studies
Organisation for Economic Co-operation and Development (OECD)
•1997Principles of Good Laboratory Practice
•ObjectiveTo promote the quality and validity of test
data used for determining the safety of chemicals and chemical products
Scope
Industrial chemicals Pharmaceuticals Veterinary drugs Pesticides, Cosmetics Food additives preservatives Basic Research Any laboratory procedure
What GLP is not
Excellence of a laboratory
Quality of an organisation
Quality of a product
Professional competence
Then, what is GLP ?
GLP indicates quality of a study/procedure.
Definition
Good Laboratory Practice is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported
(OECD, 1997)
Acceptability
Credibility
Do not assume anything
Good science = Compliance
Do not invent good practice
•Compliance with national legislation
•Compliance with national standards
•Compliance with international standards
•Validation of own standards
Terminology Quality System Quality and Requirement Calibration and Traceability Standard Reference Material Standardisation/validation Accreditation Inter-laboratory Comparison Proficiency Testing Auditing
Major ComponentsCreation of QAC; QUALITY ASSURANCE UNIT
Appointment of a STUDY DIRECTOR
Need for written protocols; SOPsSTANDARD OPERATING PROCEDURES
Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
Collection and analysis of data by QUALIFIED PERSONS
Major ComponentsCreation of QAC; QUALITY ASSURANCE UNIT
Appointment of a STUDY DIRECTOR
Need for written protocols; SOPsSTANDARD OPERATING PROCEDURES
Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
Collection and analysis of data by QUALIFIED PERSONS
QACA quality policyA quality manualControl over all documentsQuality atmosphereWell drafted ‘plan of action’
Major ComponentsCreation of QAC; QUALITY ASSURANCE UNIT
Appointment of a STUDY DIRECTOR
Need for written protocols; SOPsSTANDARD OPERATING PROCEDURES
Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
Collection and analysis of data by QUALIFIED PERSONS
Study Director
•Responsible for the study
•Has control over everything
•May have a ‘Principal investigator’
Major ComponentsCreation of QAC; QUALITY ASSURANCE UNIT
Appointment of a STUDY DIRECTOR
Need for written protocols; SOPsSTANDARD OPERATING PROCEDURES
Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
Collection and analysis of data by QUALIFIED PERSONS
A written procedure for doing everything
•SOP•Work instruction•Work procedure•work protocol
Major ComponentsCreation of QAC; QUALITY ASSURANCE UNIT
Appointment of a STUDY DIRECTOR
Need for written protocols; SOPsSTANDARD OPERATING PROCEDURES
Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
Collection and analysis of data by QUALIFIED PERSONS
Facility•Equipment
•Environment
•Raw materials
•Maintenance
Major ComponentsCreation of QAC; QUALITY ASSURANCE UNIT
Appointment of a STUDY DIRECTOR
Need for written protocols; SOPsSTANDARD OPERATING PROCEDURES
Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument
Collection and analysis of data by QUALIFIED PERSONS
People problems•Unscientific
•Untrained
•Unaware
•Unhelpful
GLP in action-I
Availability of written documentsA place for everything and everything has a placeAssessing quality of raw materialsMaintenance of equipmentPurchase of raw materialsAuthorisation to do receive, handle test materialsEnvironmental monitoringDisposal of waste
GLP in action-II
Availability of written documentsEntry restrictionsEnsuring safetyAuthorisation to do receive, handle test materialsDescribing qualification/training requirements of staffTraining of new personnel
GLP in action-III
Availability of written procedures/SOPs/protocolsReceiving test materialsIdentifying (unique) samplesHandling test materialsStoring test materialsConducting each testDisposing materialsReporting results
GLP in action-IV
Documentation in approved formatsLog book for equipmentData sheets for recording dataRecords of receipt, test proceduresApproved report formatsCompilation of data
GLP in action-V
Regular quality checksAuditing by qualified auditorsRegular reporting of NCs and/or NICsPreventive and corrective actions
GLP in action-VI
Management commitmentFor ensuring high professional standardsFor up dating procedures according to
changes in standardsParticipation in inter-laboratory comparisonsParticipation in proficiency testing
GLP in action-VII
StudyWell defined study planWell defined protocolsIdentification of critical stagesAssured performanceReporting of deviationsCompilation of data by qualified personnelsInterpretation of data by professionalsArchiving of materials/data/results
An auditors view
•What was the task?•Why perform the task?•Who performed the task?•When was it done?•How was it recorded?
•Planned Study
•Quality Performance
•Rigorous Monitoring
•Unambiguous Records
•Study Director’s Report
•Archiving of materials
Summary
Are we ready for GLP?
We are ready, when we write what we do and when we do what we write, of course in compliance withnational/international standards.
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