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

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’

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’

USA FEDERAL DRUG ADMINISTRATION  1979: Good Laboratory Practice Regulations (Revised several times)  Other agencies had endorsed the concept Eg: Environmental Protection Agency (EPA)

GLP is not an Act/Legislation/Statute GLP is a regulation/guideline

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-clinical Laboratory studies

Good Laboratory practice for non-clinical

Laboratory studies

Organisation for Economic Co-operation and Development (OECD) 1997 Principles of Good Laboratory Practice Objective To promote the quality and validity of test data used for determining the safety of chemicals and chemical products

Organisation for Economic Co-operation and Development (OECD)

1997

Principles of Good Laboratory Practice

Objective

To 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

 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

 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

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 Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

Major Components

 Creation of QAC; QUALITY ASSURANCE UNIT

 Appointment of a STUDY DIRECTOR

 Need for written protocols; SOPs

STANDARD OPERATING PROCEDURES

 Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument

 Collection and analysis of data by QUALIFIED PERSONS

Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

Major Components

 Creation of QAC; QUALITY ASSURANCE UNIT

 Appointment of a STUDY DIRECTOR

 Need for written protocols; SOPs

STANDARD OPERATING PROCEDURES

 Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument

 Collection and analysis of data by QUALIFIED PERSONS

QAC A quality policy A quality manual Control over all documents Quality atmosphere Well drafted ‘plan of action’

Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

Major Components

 Creation of QAC; QUALITY ASSURANCE UNIT

 Appointment of a STUDY DIRECTOR

 Need for written protocols; SOPs

STANDARD 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’

Study Director

Responsible for the study

Has control over everything

May have a ‘Principal investigator’

Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

Major Components

 Creation of QAC; QUALITY ASSURANCE UNIT

 Appointment of a STUDY DIRECTOR

 Need for written protocols; SOPs

STANDARD 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

A written procedure for doing everything

SOP

Work instruction

Work procedure

work protocol

Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

Major Components

 Creation of QAC; QUALITY ASSURANCE UNIT

 Appointment of a STUDY DIRECTOR

 Need for written protocols; SOPs

STANDARD 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

Equipment

Environment

Raw materials

Maintenance

Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

Major Components

 Creation of QAC; QUALITY ASSURANCE UNIT

 Appointment of a STUDY DIRECTOR

 Need for written protocols; SOPs

STANDARD 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

Unscientific

Untrained

Unaware

Unhelpful

GLP in action-I  Availability of written documents A place for everything and everything has a place Assessing quality of raw materials Maintenance of equipment Purchase of raw materials Authorisation to do receive, handle test materials Environmental monitoring Disposal of waste

GLP in action-II  Availability of written documents Entry restrictions Ensuring safety Authorisation to do receive, handle test materials Describing qualification/training requirements of staff Training of new personnel

GLP in action-III  Availability of written procedures/SOPs/protocols Receiving test materials Identifying (unique) samples Handling test materials Storing test materials Conducting each test Disposing materials Reporting results

GLP in action-IV  Documentation in approved formats Log book for equipment Data sheets for recording data Records of receipt, test procedures Approved report formats Compilation of data

GLP in action-V  Regular quality checks Auditing by qualified auditors Regular reporting of NCs and/or NICs Preventive and corrective actions

GLP in action-VI  Management commitment For ensuring high professional standards For up dating procedures according to changes in standards Participation in inter-laboratory comparisons Participation in proficiency testing

GLP in action-VII  Study Well defined study plan Well defined protocols Identification of critical stages Assured performance Reporting of deviations Compilation of data by qualified personnels Interpretation of data by professionals Archiving 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?

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

Planned Study

Quality Performance

Rigorous Monitoring

Unambiguous Records

Study Director’s Report

Archiving of materials

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 with national/international standards.