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 nonclinical

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

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 Directors 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.