This document discusses good laboratory practices (GLP). It begins by outlining the objectives and history of GLP, including how the FDA created formal GLP regulations in 1978 after discovering fraudulent activities and poor practices at toxicology labs. An example is given of a lab that falsified cancer test results on mice. The key components of GLP are then defined, including facilities, personnel, documentation, equipment, standard operating procedures, and safety. Specific guidelines are provided for these areas to ensure quality results and a safe work environment.

1. GOOD LABORATORY
PRACTICES
Magaji Amadu

2. OBJECTIVES
At the end of this session, PS would be able to;
 Define the term; good laboratory practices
 Describe procedures for maintaining a clean and
organized laboratory
 Describe standard safety measures required in a
laboratory

3. HISTORY
 GLP is a formal regulation that was created by the FDA
(United states food and drug administration) in 1978.
 In 1981 an organization named OECD (organization for
economic co-operation and development ) produced GLP
principles that are international standard.
 FDA became aware of cases of poor laboratory practice all
over the United States.
 FDA decided to do an in-depth investigation on 40
toxicology labs.
 They discovered a lot fraudulent activities and a lot of poor
lab practices.

4. FAMOUS EXAMPLE
 One of the labs that went under such an
investigation made headline news.
 The name of the Lab was Industrial Bio Test.
This was a big lab that ran tests for big
companies such as Procter and Gamble.
 It was discovered that mice that they had used
to test cosmetics such as lotion and deodorants
had developed cancer and died.
 Industrial Bio Test lab threw the dead mice and
covered results deeming the products good for
human consumption

5. THOSE INVOLVED IN PRODUCTION, DISTRIBUTION AND SALES
FOR THE LAB EVENTUALLY SERVED JAIL TIME

6. DEFINITION
GLP refers to general , but
important guidelines that should
be followed to ensure that a lab
facility meets the requirements
for producing quality results in a
safe environment

7. WHY GLP NOW?
To ensure that laboratory
investigations are conducted under
the conditions that allow the results
of the investigation to be interpreted
and presented to the medical
community with confidence.

8. COMPONENTS OF GLP
 Testing facility
 Personnel
 Quality Assurance Unit
 Testing process
 Documentation
 Equipment
 Standard Operating Procedures
 Reagents, solutions, and test kits
 Safety

9. FACILITY
 Adequate physical infrastructure in
place
 Adequate and spacious working
environment
 Water- public, borehole and
reservoir
 Electricity-Public and/or backup
 Appropriate Equipment with
backups

10. PERSONNEL
 Develop job descriptions
(duties and responsibilities)
 Provide orientation, training,
and continuing education
programs
 Assess employee competence
and performance

11. DOCUMENTS
AND RECORDS
 Develop uniform format for each
document type.
 Develop and implement a system for
document revision, approval and
distribution
 Manage patient test records. Ensure
confidentiality
 Maintain a document storage, retrieval
and destruction system

12. RECORD AND REPORTS MAINTENANCE
 1 Facility
 Organizational charts
 Personnel records
 Equipment records
 SOP’s and policies

13. HAND WRITTEN RECORDS
 All handwritten records should comply
with GLP guidelines
 Recorded promptly
 Indelible
 Signed/initialed and dated by the
person making the entry

14. DATA CORRECTIONS
 When amending data the following
procedure should be followed
 Draw a single line through the original
entry
 Record the correct value
 Sign and date the change
 Document the reason for the change
 Do not use correction fluid.

15. WHAT ARE DOCUMENTS?
 Written policies
 Process descriptions
 Procedures
 Blank forms

16. WHAT ARE RECORDS?
INFORMATION
CAPTURED ON
WORKSHEETS,
LOGBOOKS,
FORMS AND
CHARTS
RECORDS

17. WHY DOCUMENTATION AND RECORD KEEPING?
 Permanent and tangible testimony
 Follow-up
 Data collection
 Research purpose
 Easy reference
 Monitoring and evaluation of
laboratories
 Planning

18. CONSIDERATIONS
 Simple and clear to understand
 Easy to access
 Provide Right and necessary information
 Durable
 Duplicates or Back-up should be
provided

19. REQUIREMENTS FOR RECORD KEEPING
Materials;
 Note books/registers
 Writing materials
 Files/folders/binders
 Electronic devices e.g. computers,diskettes,
CDs.
Storage Facilities
 File Cabinets
 Drawers/cupboards

20. ITEMS THAT NEED DOCUMENTATION
 SOPs
 Specimens
 Laboratory Results
 Corrective Actions
 Temperature
 Materials and stock received
 Equipment Maintenance
 Personnel items
 Requests /Orders placed

21. STANDARD OPERATING PROCEDURES (SOPS)
 Written procedures which describe
how tests or activities are performed.
 Clear, simple and direct to the point
 Communicated in the fewest possible
words,
 Complete - containing all the
necessary information to perform the
procedure,
 Steps must be listed sequentially.

22. TYPES OF SOPS
 Specific SOPs: refer to a specific test,
procedure or assay. Examples;
Determine SOP or Statpak SOP
 General SOPs: Do not pertain to a
specific test, procedure or assay.
Examples: Processing, Safety, QA

23. USES OF SOPS
Ensures consistent quality of
work
Provides guidance for
solving problems when
results fail to meet the
expected quality standards

24. USES OF SOPS
Best way to maintain optimal
quality of results
Enables everyone working at
the testing site to understand
the various procedures
Provides a stable pattern of
function

25. COMPONENTS OF GENERAL SOPS
 Definition
 Purpose
 Scope
 Policy
 Responsibilities
 References
 Chart, or etc.

26. EQUIPMENT SOPS
Additional Information May Include
 Services
 Maintenance
 Calibration
 Troubleshooting
 Repairs
 Contact Information

27. REFERENCES FOR SOPS
 Package Inserts
 Manuals
 Journals
 Text Books
 Internet

28. CORRECTIVE ACTIONS FORM
 Used to document problems in the
laboratory and corrective actions
taken, example;
a) Pre-analytical, e.g. room
temperature out of range
b) Analytical, e.g. instrument fail,
controls fail
c) Post-analytical, e.g. transcriptional
error

29. Remember,
 If there is no documentation, then you
did not do it
 Documentation is the only proof you
have to your claim.

30. SAFETY IN THE LABORATORY
 Why Is Safety Important?
 Performing testing is a potential
health hazard.
 Safety involves taking precautions to
protect yourself and your client
against infection.

31. UNIVERSAL PRECAUTIONS
Universal precautions are simple infection
control measures that reduce the risk of
transmission of bloodborne pathogens
through exposure to blood or body fluids
among patients and health care workers.
Under the “universal precaution” principle,
blood and body fluids from all persons
should be considered as infected with
HIV, regardless of the known or
supposed status of the person,
( WHO definition).

32. EVERY INDIVIDUAL’S
SPECIMEN SHOULD BE
TREATED AS INFECTIOUS

33. WHAT ELSE NEEDS
PROTECTION?
Other People
Products
Environment

34. HOW IT IS DONE
Ensure Universal Precautions
 Barrier Protection should be used
whenever samples are obtained from
patients.
 Personal protective equipment should be
worn in the laboratory when handling and
processing specimens and performing
diagnostic testing.
 All technical procedures should be
performed in a way that minimizes the
creation of aerosols, droplets, splashes or
spills.
 Mouth pipetting of all substances should be
prohibited.
X
YES
NO

35. HOW IT IS DONE
 After use, hypodermic needles should
not be recapped, clipped or removed
from disposable syringe. The complete
assemble should be placed in a sharps
container.
 Adequate and conveniently located
biohazard containers should be
available for disposal of contaminated
materials.
 Designate all lab areas and equipment
as “Dirty” or “Clean” (including benches,
desks,refrigerators,freezers and sinks)

36. HOW IT IS DONE
 Work surfaces must be
decontaminated after any spill of
potentially dangerous materials at the
end of the working day.
 Personnel must wash their hands,
before leaving the laboratory working
areas and before eating.
 Personal protective clothing must be
removed before leaving the
laboratory.

37. DEVELOP PERSONAL SAFE WORK
HABITS
 Pipetting by mouth is
strictly forbidden
 Never eat, drink or
smoke at the test site
 Keep food out of the
laboratory/testing site
refrigerator
 Do not apply cosmetics
in the laboratory
Lab workers Health workers Counselors

38.  Thank you