Defined in the OECD Principles as: “...a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”
2. The Birth Of GLP
-In the early 1970s, the FDA
investigated a number of cases of
poor practice in toxicology
laboratories throughout the USA
- Results of this investigation in about
40 laboratories revealed many cases of
poorly managed studies, insufficient
training of personnel, and some cases
of deliberate fraud
- In 1976, the FDA published a draft
regulation on GLP
- After the consultation period, the
final regulation was published in 1978
- This came into force in 1979
- Many countries introduced their own
GLP Regulations
- The OECD produced GLP Principles
in 1981.
These regulations have now become
the international standard in the
domain
3. What is GLP?
Defined in the OECD Principles as: “...a quality
system concerned with the organizational
process and the conditions under which non-
clinical health and environmental safety
studies are planned, performed, monitored,
recorded, archived and reported.”
4. GLP Aims
1
To make incidence
of False Negatives
more obvious
(False negative : Results
demonstrate non-toxicity of a toxic
substance)
2
To make incidence
of False Positives
more obvious
(False positive : Results demonstrate
toxicity of a non-toxic substance)
3
To promote mutual
recognition of study
data across
international frontiers
5. Main / fundamental Points in GLP
considerations
Resources
• Organization, personnel, facilities - building and equipment
Rules
• Protocols / Study plan, SOPs
• concept of the Study Director as the pivotal point of study control
Characterization
• Test items & test systems
Documentation
• Raw data, final report, archives.
Quality assurance
• Independence from study conduct
6. RESOURCES
Buildings: Adequate Separations
Physical separations:
Rooms
Cabinets / Isolators
Air systems and filters
Separation by work areas
Defined work areas
One-way systems
Different activities in same areas at
different times
Cleaning between activities
Separate staff
GLP WHO Training manual
7. Characterization
Test Item
GMP is not required for manufacture of
GLP batches
Regulatory Authorities require testing to
ensure test items suitability for
preclinical studies
Use single lot throughout study if
possible
Protect test item from cross
contamination/pollution
Ensure traceable records for test items
What are Test Systems ?
Animals
Bacterial
Cells
Organs
Plants
can also be
Analytical equipment
8. Rules
The protocol (or study plan)
which describes how the study
is designed and how it is to be
conducted, including the
expected timeframe of the
study
Approval of the Protocol
(study director)
Distribution of the Protocol
Protocol Amendments
The standard operating
procedures (SOP) which
provide detailed instructions
about how to actually perform
each technical procedure, and
how to ensure sound
organization of the study, its
environment and data
9. Documentation: Results
Records and recording
- The raw data should
include:
“WHAT was done”
“HOW it was done”
“WHEN the work was
performed”
“WHO performed
the work”
FINAL REPORT (study director)
Accurate Reporting and Deviations
Statement of compliance to GLP
standards and validity of data
What is Archived?
• Study data
• Personnel data
• Systems data
• Quality assurance files
10. Quality Assurance
In summary, the fundamental mission of QA is that of an independent
witness to the whole preclinical research process and its organizational
framework
To respect GLP Principles, QA must review all phases of preclinical research -
from planning to reporting and archiving of the documentation
To be effective, QA must have access to staff documents and procedures at
all levels of the organization, and be supported by a motivated top
management
the signed QA statement becomes a “release” document (not a GLP
compliance statement)