The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms. The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.

1. PRESENTED BY : Dr. RAJIV RANJAN DAS
GUIDE : Dr. (PROF AND HOD ) U.S.P. KESHARI

2. Why GLP?
The concept of GLP originated in US because
of concerns about the validity of non
clinical safety data submitted to the FDA
the context of NDA

3. Learning objectives
• To Understand the definition and concept of GLP
• To know the importance of standard operating procedure(SOP) in GLP
• To differentiate between quality assurance and quality control
• To understand the definition and concept of SOP and Protocol

4. GOOD LABORATORY PRACTICE (GLP)
is a requirement and necessity for a laboratory to
increase the validity and confidence in the quality
data received out of a experimental procedure which
must be reliable, consistent and reproducible
It is defined in OCED principles as “ a quality system
concerned with the organizational process and the
conditions under which non clinical health and
environment safety studies are planned, performed ,
monitored , recorded, archived and reported .”
OECD Principles on Good Laboratory Practice (as revised in 1997)

5. Good Laboratory Practices has been made as law by introducing it as
Schedule L-1 which is a New Schedule under Drugs and Cosmetics
Rules, 1945 vide Gazette notification no GSR 780 (E) 10-11-2008
with effect from 1-11-2010. Consequent to this amendment, Rule 74,
78 and Rule 150E of the Drugs and Cosmetics Rules, 1945 have
been amended. It involves a number of good practices in the Quality
Control laboratory which are to be undertaken to carry out an analysis
with a defined degree of Accuracy & Precision
AMENDMENT

6. Since raw materials, packaging materials, intermediates and finished
products are ultimately released based on the analytical results generated
in the Q.C. Laboratory, Accuracy, Precision and Reliability of these results
are of paramount importance
IMPORTANCE OF GLP

7. HISTORY

8. 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
DOI: 10.1007/978-3-211-89836-9_613 · Source:
InTech

9. • Poorly-trained Study Directors and study personnel
• Poorly-designed protocols
• Protocols not followed - procedures not conducted as prescribed
• Raw data badly collected - not correctly identified - without traceability - not
verified or approved by responsible persons
• Lack of standardized procedures
• Poor animal husbandry
FDA INVESTIGATION FINDING
DOI: 10.1007/978-3-211-89836-9_613 · Source: InTech

10. • Inadequate characterisation of test items and test systems
• Inadequate resources
• Equipment not properly calibrated or otherwise qualified
• Reports not sufficiently verified, inaccurate account of study
or raw data
• Inadequate archives and retrieval processes
FDA INVESTIGATION FINDING
DOI: 10.1007/978-3-211-89836-9_613 · Source: InTech

11. • Introduce a new regulation to cover
NON-CLINICAL SAFETY STUDIES
• Good Laboratory Practice regulations
 Draft USA GLP in 1976
 An enforceable USA regulation in 1979
FDA DECISION
DOI: 10.1007/978-3-211-89836-9_613 · Source: InTech

12. HISTORY CONTD..
• GLP is a formal regulation that was created by the FDA in 1978
• In 1981 an organization named OCED (organization for
economic co-operation and development ) produced GLP
principles that are international standard
• Non US companies that wanted to do business with the US , had
to comply with the norms of United states GLP regulations
DOI: 10.1007/978-3-211-89836-9_613 · Source: InTech

13. Objectives of GLP
• GLP makes sure that the data submitted are true reflection of the
results that are obtained during the study
• GLP also makes sure that not to indulge in any fraud activity by labs
• Promotes international acceptance of tests
• GLP promotes quality and validity of test data
OECD Principles on Good Laboratory Practice (as revised in 1997)

14. To help scientists obtain results that
are:
Main goal of GLP
• Reliable
• Repeatable
• Auditable
• Recognized

15. LIMIT WASTE OF
RESOURCES
ENSURE HIGH
QUALITY OF
RESULTS
ENSURE
COMPARABILITY OF
RESULTS
PROMOTE MUTUAL
RECOGNITION OF
RESULTS
(Preamble to European Directive 87/18 EEC)

16. Principles of GLP
1. Quality assurance program
2. Apparatus materials reagents
3. Test system
4. Test and reference substances
5. SOP
6. Facilities
7. Performance of study
8. Reporting of study results
9. Storage and retention of records
10. Testing facility organization and personnel

18. FIVE BASIC POINTS:
1. Resources: organization, personnel, facilities and equipment
2. Characterization: Test items/ARTICLE: identification , quality…
Test systems : identification , health status…..
3. Rules: Study plans (or Protocols) and written procedures
4. Results: Raw data, final report and archives
5. Quality assurance : Audit/inspection –training-advice

19. 1. Resources
• Organization and personnel
GLP regulations require that the structure of R&D organizations and the responsibilities
of R&D personnel be clearly defined GLP also stresses that there should be sufficient staff to
perform the tasks required. The qualifications and the training of staff must also be defined and
documented
• Facilities and equipment
The regulations emphasize the need for sufficient facilities and equipment to perform
the studies.
All equipment must be in working order. To ensure this, a strict programme of qualification,
calibration and maintenance must be adopted

20. 2. Characterization
• In order to perform a study correctly, it is essential to know as much as possible
about the materials used during the study
• For studies that evaluate the properties of pharmaceutical compounds during
non-clinical studies, it is a prerequisite to have details about the test item and
the test system (often an animal or plant) to which the test item is to be
administered

21. 3. Rules
Protocols and written procedures
• The main steps of research studies are prescribed in the study plan or protocol.
Being
able to repeat studies and obtain similar results is a sine qua non of mutual
acceptance of
data and, indeed, a central tenet of the scientific method, so the details of routine
procedures must also be available to scientists involved in the study
• However, the protocol,which provides the experimental design and timeframe for the
study, does not contain all the technical detail necessary to conduct the study. These
details are found in written standard operating procedures (SOPs). With the protocol
and the SOPs it should be possible to repeat the study exactly, if necessary

22. 4. Results
Raw data
All studies generate raw data. These are the outcome of research and form the basis
establishing scientific interpretations and arriving at conclusions. The raw data must a
reflect the procedures and conditions of the study
Final Report
The study report contains an account of the way in which the study was performed,
incorporates the study results and includes the scientific interpretation of the data. The
report is provided to regulatory authorities as part of the submission for registration an
marketing approval
Archives
Storage of records must ensure safekeeping for many years and allow for prompt
retrieval

23. 5. Quality Assurance
• Quality assurance (QA), as defined by GLP, is a team of persons (often called the
quality assurance unit – QAU) charged with assuring management that GLP
compliance has been attained within the laboratory
• QA must be independent from scientists involved in the operational aspects of the study
being performed. QA functions as a witness to the whole non-clinical research process

24. GLP REGULATIONS
SUMMARY
n Akyar (2011). GLP: Good Laboratory Practice, Modern Approaches To Quality Control, Dr. Ahmed Badr
Eldin (Ed.), ISBN: 978-953-307-971-4,

25. n Akyar (2011). GLP: Good Laboratory Practice, Modern Approaches To Quality Control, Dr. Ahmed Badr
Eldin (Ed.), ISBN: 978-953-307-971-4,

26. n Akyar (2011). GLP: Good Laboratory Practice, Modern Approaches To Quality Control, Dr. Ahmed Badr
Eldin (Ed.), ISBN: 978-953-307-971-4,

27. SOP & GLP
• A testing facility shall have standard operating procedures in writing setting forth
nonclinical laboratory study methods are adequate to ensure the quality and integrity
of the data generated in the course of a study
• Each laboratory area shall have immediately available laboratory manuals and standard
operating procedures procedures relative to the laboratory procedures being
performed .
• Published literature may be used as a supplement to SOP
• A historical file of SOP and all revisions thereof , including the dates of such revisions ,
shall be maintained

28. • CONTENTS/CHARACTERISTICS OF SOP
Total integration
Comprehensive coverage
Readability
Usability and traceability
Understanding
Responsibility
Change control
Centalised organization
Availability and
Archieving