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.