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’
 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
Code of Federal regulations
(Food and Drug Administration)
Part 58
•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
 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 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

 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

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

Facility
•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

People problems
•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?
 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.