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.
