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1. THE IMPORTANCE OF GOOD LABORATORY
PRACTICE IN THE EFFECTIVE MANAGEMENT OF
THE LABORATORY
PRESENTED
BY
NGONADI JULIET CHINENYE
TO
CHEMICAL PATHOLOGY DIVISION
SUPERVISED BY MR OLUSEGUN OYEWOLE (DDMLS)
&
MR KELVIN ODEH
9TH FEBRUARY, 2021.
2. OUTLINE
• Abstract
• Introduction
• History
• Objectives
• Regulation Governing Laboratory Personnel
• Missions of GLP
• General Laboratory Safety Rules
• Medical Laboratory Science Code of Professional Ethical Conduct
• Laboratory Equipment Management
• Laboratory Turnaround Time
• Do this for GLP
• Recommendation
• Conclusion
• References
3. ABSTRACT
• Good Laboratory Practice {GLP} play an important role in ensuring , consistency,
reliability, reproducibility and quality of laboratory tests.
• It provides a frame work for laboratories to plan, perform , monitor, record and
report their activities .
• It also reflects the quality of laboratory services during any assessment and
accreditation process.
4. INTRODUCTION
• Good Laboratory Practice (GLP) embodies a set of principles that provides a framework
within which laboratory studies are planned, performed, monitored, recorded, reported
and archived (Stiles et al., 2013).
• Good Laboratory Practice (GP) is intended to promote the quality and validity of test
data.
• In clinical chemistry laboratory the concept of good laboratory practice is essential
because it ensures that the results generated from the laboratory are reproducible, precise
and accurate (Bull et al., 2007).
5. HISTORY.
• GLP was first introduced in 1970s in New Zealand Denmark.
• A few years later by the Organization for Economic Co- Operation and
Development [OECD] helped promulgate GLP to many countries, GLP discovered a
lot of fraudulent activities of poor laboratory practices.
• GLP, a data quality system ,should not be confused with standards of laboratory
safety.
6. OBJECTIVES
• GLP approves that every step of analysis is valid
• GLP, makes sure data is traceable
• It promotes International acceptance of Tests
• GLP has great emphasis on data recording archives and specimen retention
• To ensure quality and integrity of data submitted to FDA in regards to safety of
regulated products.
7. REGULATION GOVERNING LABORATORY
PERSONNEL
• In Nigeria the body concerned with the regulation of laboratory practice is the Medical
Laboratory Science Council of Nigeria (MLSCN).
• The body is concerned with regulation, accreditation and issuance of licensure to
practice as a medical laboratory scientist in Nigeria (MLSCN Act II, 2003).
8. LABORATORY SAFETY
• Laboratory safety guidelines are measure taken in the laboratory to prevent laboratory
related accidents.
• The safety measures includes, safety training, enforcement of laboratory safety policies,
safety review of experimental designs.
• The use of personal protective equipment and the use of the buddy system for
particularly risky operations (Bull et al., 2007).
10. MISSIONS OF GLP
• Test facility organization and personnel
• Storage, archiving of records and materials
• Apparatus, materials and reagents facility.
• Test and reference substances
• Test systems
• Quality assurance programs – QAP
• Standard Operating Procedures
11. QUALITY CONTROL
• Quality Control is defined as a system for verifying and maintaining a desired level
of quality in an individual test or process (Kilinc, 2009).
• Includes inspections to determine compliance of study with GLP missions.
• It gives access to the updated study plans of SOP
12. MEDICAL LABORATORY SCIENCE CODE OF
PROFESSIONAL ETHICAL CONDUCT
• Duty to the Patient
• Duty to Colleagues and the Profession
• Duty to Society
(Kilinc, 2009).
13. LABORATORY EQUIPMENT MANAGEMENT
Equipment management is one of the essential elements of a quality management
system. Proper management of the equipment in the laboratory is necessary to ensure
accurate, reliable and timely testing (Plebani et al., 2014).
Preventive maintenance includes measures such as:
• Systematic and routine cleaning,
• Adjustment and replacement of equipment parts at scheduled intervals.
14. LABORATORY TURNAROUND TIME
• The turnaround time (TAT) as defined by most of the laboratories is the time interval
between the specimens received in the laboratory to the time of reports dispatched with
verification (Saxena and Wong, 2013).
• Turnaround time (TAT) is one of the most noticeable signs of laboratory service and is
often used as a key performance indicator of laboratory performance.
15. DO THIS FOR GLP
• Give names of location of everything and keep things at its proper location after use.
• Identify things with its name / purpose using proper storage containers.
• Prepare location list and display points for SOPs .
• Use ladders for things stored above eye level.
• Establish proper areas for storage of incoming samples as well as test completed samples.
• Take care of all safety points .
• Ensure good ventilation , proper illumination and prefer natural lighting.
• Air conditioned lab with humidity control should be introduced.
• Provide enough space for measuring and testing instrument
16. RECOMMENDATION
• I strongly recommend that stringent measures should be put in place to ensure that
good laboratory practice guidelines are adhered to by Medical laboratory
Professionals.
17. CONCLUSION
• The Good Laboratory Practice (GLP) standards were developed to bring together
multiple guidance and regulatory information, as they apply to clinical research and
to fill a void of a single.
• To maintain a GLP environment for a clinical trial it is critical that all of the key
GLP elements are in place and operational.
18. REFERENCES
• Brow, J. (2012). "When culture and medicine collide". The
Dental Assistant. 71:3 (3): 26.
• Bull, M., Lee, D., Stucky, J. and Chiu, Y.L. (2007). Laboratory
Procedures. Journal of Immunology and Methods. 322: 57–69.
• Fung, M.K. (2014) Technical Manual 18th ed. Bethesda,
Maryland, USA:AABB; 2014. P.376.
• Horton, H., Thomas, E.P., Stucky, J.A. and Frank, I., Moodie,
Z. and Huang, Y. (2007). Journal of Immunology and
Methods. 323:39–54.
• Kilinc, C. (2009). Laboratory quality management systems: missions, goals and
activities in quality assurance. Clinical Biochemistry. 42(4–5): 301–312.
• Medical Laboratory Sciences Council of Nigeria (MLSCN) (2003). Federal Statutory
Parastatal Established by Act II, 2003.
19. REFERENCES
• Plebani, M., Sciacovelli, L., Aita, A., Padoan, A. and Chiozza, M.L. (2014). Quality
indicators to detect pre-analytical errors in laboratory testing. Clinical Chimica.
432: 44–48.
• Richmond, J.Y. and McKinney, R.W. (2010). Primary containment for biohazards:
selection, installation and use of biological safety cabinets, 2nd ed. United States
Government Printing Office, United States Department of Health and Human
Services Public Health Service, Centers for Disease Control and Prevention, and
National Institutes of Health.
• Saxena, S. and Wong, E.T. (2013). Does the emergency department need a
dedicated stat laboratory? Continuous quality improvement as a management tool
for the clinical laboratory. America Journal of Clinical Pathology. 100: 606–610.
• Stiles, T., Grant, V. and Mawby, N. (2013). Good Clinical Laboratory Practice
(GCLP): A Quality System for Laboratories that undertake the Analyses of Samples
from Clinical Trials.
