Oecd principles of GLP

Oecd principles of GLP

1. Major Advisor : Dr. K.
Jayakumar
Speaker : Amol R. Padol
CREDIT SEMINAR-I

2. INTRODUCTIONINTRODUCTION

3. OECD ???
oan intergovernmental organisation.
oRepresentatives of 30 industrialised countries in North
America, Europe, Pacific and the European Commission.
oTo co-ordinate and harmonize policies, discuss issues of
mutual concern, and work together to respond to
international problems.

4. oEnvironmental Health and Safety Division.
oThe Principles of GLP have been developed to
promote the quality and validity of test data used for
determining the safety of chemicals and chemical
products (Schechtman, 2007)

5. Good Laboratory PracticeGood Laboratory Practice
oA 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/ENV/MC/CHEM,1998)

6. oIts principles are required to be followed by test
facilities carrying out studies to be submitted to
national authorities.
oCommon principles for GLP
facilitate the exchange of
information and prevent the
emergence of non-tariff
barriers to trade.
(Berend, 2002)

7. oThe issue of data quality has an important
international dimension.
oIf regulatory authorities in countries can rely on safety
test data developed abroad, duplicative testing can be
avoided.

8. HISTORYHISTORY

9. oThe GLP regulations for non-clinical laboratory studies
published by the US-FDA in 1976 (Baldeshwiler, 2003).
oThe OECD Principles of GLP were first developed by an
Expert Group on GLP established in 1978 under the
Special Programme on the Control of Chemicals.
oPrinciples of GLP were adopted by the OECD in 1981.

10. oExpert Group was established in 1995 to develop a
proposal to revise the Principles of GLP.
oThe Revised OECD Principles of GLP were reviewed in
the relevant policy bodies of the Organisation and were
adopted by Council on 26 November, 1997.
oIndian GLP Compliance Monitoring Authority - April,
2002.

11. SCOPESCOPE

12. Principles of GLP should be applied to the non-clinical
safety testing of test items contained in,
Pharmaceutical products
Pesticide products
Cosmetic products
Veterinary drugs
Food and feed additives
Industrial chemicals.

13. oTest items: synthetic chemicals, natural or biological
origin and, may be living organisms.
oSafety studies covered by the Principles of GLP include
work conducted in the laboratory, in greenhouses, and
in the field (Jena et al ., 2009)
oPrinciples of GLP apply to all non-clinical health and
environmental safety studies required by regulations for
the purpose of registration.

14. GOOD LABORATORY PRACTICE
“PRINCIPLES”

15. Key Personnel in GLP

16. Test Facility Management
oThe person(s) who has the authority and formal
responsibility for the organisation and functioning of the
test facility.
Responsibilities
oMaintenance of a record of the qualifications, training,
experience and job description for each professional and
technical individual.

17. oAppropriate and technically valid SOPs are established
and followed.
oQuality Assurance Programme is being performed in
accordance with the Principles of GLP.
oIndividual with the appropriate qualifications, training,
and experience is designated by the management as the
Study Director before the study is initiated.

18. oIn the event of a multi-site study, a Principal Investigator
is designated.
oTest Facility Management should ensure the
documented approval of the study plan by the Study
Director.
oEnsure that the SD has made the approved study plan
available to the QA personnel.

19. oAn individual is identified as responsible for the
management of the archive(s).
oFor a multi-site study clear lines of communication
should exist between the SD, Principal Investigator(s),
the QAP(s) and study personnel.
oComputerised systems should be validated, operated
and maintained in accordance with Principles of GLP
(Udaka and Horii, 1985)

20. Study Director
oThe individual responsible for the
overall conduct of the nonclinical
health and environmental safety
study.
oThe single point of study control.

21. oApprove the study plan and any amendments by dated
signature.
oSD should ensure that the QA personnel have a copy of
the study plan and any amendments.
oStudy plans (and amendments) and SOPs are available
to study personnel.
Responsibilities of SD

22. oSD should ensure that all raw data generated are fully
documented and recorded.
oComputerised systems used in the study should be
validated (Taylor, 1984)
oSD should sign and date the final report to indicate
acceptance of responsibility for the validity of the data.

23. oSD should ensure that after
completion of the study,
the study plan
the final report
raw data
supporting material
are archived.

24. Principal Investigator
oan individual who, for a multi-
site study, acts on behalf of the
SD and has defined
responsibility for delegated
phases of the study.
oThe PI should ensure that the
delegated phases of the study
are conducted in accordance
with the Principles of GLP.

25. Responsibilities of Study Personnel
oKnowledgeable in those parts of the Principles of GLP
which are applicable to their involvement in the study.
oAccess to the study plan and appropriate SOPs.
oAny deviation from these instructions should be
documented and communicated directly to the SD, or
the Principal Investigator.

26. oResponsible for recording raw data
promptly and accurately and for the
quality of the data.
oStudy personnel should exercise
health precautions to minimise risk
to themselves and to ensure the
integrity of the study
(Schechtman, 2007).

27. Quality Assurance
Programme
o"an internal control system designed to ascertain that
the study is in compliance" with the Principles of GLP.
oThe test facility should have a documented QAP.
oAn individual or individuals designated by
management, who are familiar with the test
procedures (Hughes, 1999)
oshould not be involved in the conduct of the study
being assured (Becker et al., 2009)

28. oMaintain copies of all approved study plans and SOPs.
oVerify that the study plan contains the information
required for compliance with the Principles of GLP.
oConduct inspections to determine that all studies are
conducted in accordance with the Principles of GLP.
(Hughes, 1999)
Responsibilities of the QA-
Personnel

29. oInspect the final reports to confirm that,
the methods, procedures and observations are
accurately and completely described.
reported results accurately and completely reflect the
raw data of the studies.

30. oPromptly report any inspection results in writing to
management and to the SD, or Principal Investigator(s).
oPrepare and sign a statement, which specifies types of
inspections and their dates, including the phase(s) of the
study inspected.

31. Facilities
oSuitable size, construction and location to meet the
requirements of the study.
oAdequate degree of separation of the different activities
to assure the proper conduct of each study
(Garner and Barge, 1989)

32. Facilities for Handling Test and
Reference Items
oSeparate areas for receipt and storage of the test and
reference items, and mixing of the test items with a
vehicle.
oStorage areas for the test items should be separate from
areas containing the test systems.
oStorage areas should be adequate to preserve identity,
concentration, purity, and stability.

33. Archive Facilities
oArchive facilities should be provided for the secure
storage and retrieval of study plans, raw data, final
reports, samples of test items and specimens.
Archive design and archive
conditions should protect
contents from untimely
deterioration (Udaka and Horii,
1985)

34. Waste Disposal
oHandling and disposal of wastes
should be carried out in such a way
as not to jeopardize the integrity of
studies.
oProvision for appropriate
collection, storage and disposal
facilities, and decontamination and
transportation procedures.

35. Apparatus, Material and Reagents
oApparatus should be suitably located and of
appropriate design and adequate capacity.
oPeriodically inspected, cleaned, maintained, and
calibrated according to SOPs.
oApparatus and materials used in a study should not
interfere adversely with the test systems
(Stevenson, 1992)

36. oChemicals, reagents, and solutions should be labelled to
indicate identity, expiry date and specific storage
instructions.
oInformation concerning source, preparation date and
stability should be available.

37. Test SystemsTest Systems
oany biological, chemical or physical
system or a combination thereof
used in a study.
Physical/ChemicalPhysical/Chemical
Location
Design
Capacity.

38. oProper conditions should be established and maintained
for the storage, housing, handling and care of biological
test systems.
oNewly received animal and plant test systems should be
isolated until their health status has been evaluated.
oAcclimatised to the test environment.
Biologica
l

39. Standard Operating
Procedures
oA test facility should have written
SOPs approved by test facility
management.
oLanguage interpretable to those who
are going to use them (Federick, 2006)
Documented procedures which
describe how to perform tests or
activities normally not specified in
detail in study plans or test guidelines.

40. oDeviations from SOPs should be
documented and acknowledged by the
SD or the Principal Investigator.
oPublished text books, analytical methods,
articles and manuals -supplements to the
SOPs.
oReviewed regularly.

41. oSOPs should be available for the following categories of
activities:
Test and Reference Items
Apparatus, Materials and Reagents
Record Keeping, Reporting, Storage, and Retrieval
Test System
Quality Assurance Procedures.

42. Content of the Study Plan
oIdentification of the study, the test item and reference
item.
oInformation concerning the sponsor and the test
facility.
oDates
oTest Methods
oRecords

43. Conduct of the Study
oA unique identification should be given to each study,
all items concerning this study should carry this
identification (Royal, 1994)
oSpecimens from the study should be identified to
confirm their origin.
oConducted in accordance with the study plan.

44. oData generated should be recorded directly, promptly,
accurately and signed and dated.
oAny change in the raw data should indicate the reason
for change and should be dated and signed by the
individual making the change.
oComputerised system should always provide for the
retention of full audit trails to show all changes to the
data without obscuring the original data.

45. Reporting of Study
Results
oThe final report should be signed and dated by the SD
to indicate acceptance of responsibility for the validity
of the data.
oThe extent of compliance with the principles of GLP
should be indicated.
oAmendments should clearly specify the reason for the
corrections or additions and should be signed and
dated by the SD
(Ranade, 2007)

46. Content of the Final
Report
oThe final report should include,
Identification of the Study, the Test Item and
Reference Item.
Information concerning the Sponsor and the Test
Facility.
Dates
QAP statement
Description of Test Methods
Results
Storage (study plan, test and reference items, specimens, raw
data)

47. Mutual Acceptance of Data
oTesting of chemicals is labour-intensive and expensive,
and testing the same chemical in several countries adds
to the cost in time, resources and laboratory animals.
oTo relieve some of this burden, the OECD Council
adopted the concept of MAD in 1981.

48. oMutual Acceptance of Data:
“Data generated in a member country in accordance
with OECD Test Guidelines and Principles of GLP shall
be accepted in other member countries for assessment
purposes and other uses relating to the protection of
human health and the environment.”
(Turnheim , 2008)

49. oOECD Council sets out a step-wise procedure for non-
OECD countries with a major chemical industry to take
part in the work of OECD (Sasaki et al., 2009)
oThis leads to full membership in the part of OECD
related to the MAD.
oSouth Africa was the first non-OECD country to have
completed this process and to have been invited to join
the system as a full member.

50. oSlovenia and Israel - full members.
oArgentina, Brazil, India (2003) , Malaysia and
Singapore are the provisional adherents.
oThe provisional adherence procedures have begun for
Thailand.

51. National GLP Compliance Monitoring
Authority (NGCMA)
oApril, 2002
oDepartment of Science and Technology (DST).
oProvisional Member of the OECD for GLP.
oHead, National GLP Programme has been nominated
by the Department as an Observer to the OECD’s
Working Group on GLP.
ofunctions as per OECD Norms & Principles and efforts
are being made to achieve OECD recognition, so that
India acquires full-member status in OECD (Stanley, 2009)
There is still long way to go……………..!

52. CONCLUSIONCONCLUSION

53. oThe purpose of GLP is to assure the quality and integrity
of data submitted in support of the safety of regulated
products.
oProtocols, SOPs, adequate facilities, and equipments,
identification of test substance, proper animal care,
accurate recording of observations and adequate
reporting of results are basic necessities for the conduct
of high quality valid toxicity study.

54. oTest results obtained in compliance with GLP are to be
mutually accepted by the health authorities and
environment authorities of the OECD member states.
Therefore, multiple testing can be avoided.