The implementation of the OECD Principles of Good Laboratory Practice (GLP) represents a significant challenge to novice organizations. The aim of the document is to provide a sequential framework for GLP implementation. Although there are many ways to achieve GLP compliance, the steps recommended here are based upon the practical experience of scientists who have already implemented GLP.

1. Stepwise
Implementation
Of
Good laboratory
practices
Mohamed Minas M
200522601017

2. Table of contents
01 03
Responsibility Quality Assurance
Organization Facility
02 04

3. Table of contents
05 07
Establishment
Archive of
documentation
Apparatus, Materials
& Reagents
Raw Data
06 08

4. Organization
01.

5. Study Directors,
Quality Assurance
personnel, Archivist.
Arrange
General GLP
training for all
faculty.
Management
should
nominate
Establish an
organisational
schemes for the
management.
Set up the standard
format for personally
identifiable
information.

6. Organise personnel records
for all personnel using
agreed formats.
Prepare a SOP for the firm, analyse it and
reform for staff organization charts and
documents.
Decide who will be responsible for managing your
organization's SOP system and set your system in a
SOP and all new SOPs will be managed by the
specified system.
Establish archives and
Write an SOP for the
archiving process.

7. Responsibility
02.

8. Approval of protocol
and study plans
including
amendments and
access to the SOP
Write a workflow
SOPs for protocols
Technical conduct of
the study, thus
supervisors should
have the knowledge
of the GLP principles
Comply with the
instruction of the SOPs
and record the raw data
and ensure
Interpretation, analysis,
documentation and
reporting of the results.
2.1 2.2 2.3 2.4

9. 03
Facility

10. Agree on a system for identifying
equipment and instruments among
all interested parties and this
procedure is implemented.
Physically identify (tag) all
equipments listed as per the
system.
List all the equipment and
instruments and utilized within
the research facility.
Write a SOP in the equipment
log book (lifecycle approach),
its importance and use. Log
books for each equipment
should be there.

11. Determine which maintenance
operations require external
contracts and Sign contracts
with contractors and contract
should be documented.
Equipment shall be adequately
inspected, cleaned and
maintained and procedure
should be implemented and
appoint a person for
maintainance.
Laboratories should be well
ventilated, free of dust, drafts and
extreme temperatures.
Documented Inspection, cleaning,
maintenance and calibration of
apparatus. Identify major
equipment that need to be
officially qualified.
Qualify the systems selected
to qualify.

12. Quality Assurance
Unit
04.

13. Set up a quality
assurance unit
Develop the QA program
based on the three inspection
methods and determine any
deviation from the approval
protocol and report to SD and
management
Train QAU staff in
verification and inspection
techniques

14. Apparatus,
Materials &
Reagents
05

15. Reagents used in
the operation
should be
specified in the
SOPs.
Set up rules
and write
SOPs for
solution
preparation,
etc.
Establish rules for
identifying, handling
& storing all reagent
components
5.1 5.2 5.3

16. 04. 06.
Establishment

17. Set rules for
acquiring,
modifying &
approval of raw
data
Define the raw data
audit process in all
operating units and
develop SOPs for
the verification and
QC work

18. Raw Data
07

19. List all computer
systems used
throughout the
organization
Identify systems
that need formal
validation
Prepare formal
validation protocols
for systems that
need to be validated
Perform validation
tests as per
validation protocols.
7.1
7.3
7.2
7.4

20. Draft formal validation reports for
approved systems
Educate all personnel to
operate computer systems
they need
Write SOPs for using
and maintaining
computer systems
Formally “deploy” the
system upon completion
of validation and training
Set rules for organizing
access rights and
passwords and
write SOP for that
process

21. Archive of
documentation
08

22. Look at existing SOPs
and list all remaining
SOPs
Create a guiding calendar
for all current studies
within the organization
Create a timeline to complete
these SOPs and Add authors'
names and allow time for an
appropriate revision before
signing
Carry out a second gap
analysis to identify any
remaining gaps in GLP
compliance

23. Thank
You!