describes about rules and regulations in ICH

1. Under the guidance of
Ms. Srujani M.Pharm., (PhD).
Submitted by
S. Srilakshmi
M.Pharm. 1st Year
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Department Of Pharmaceuticals Analysis
ACHARYA NAGARJUNA UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES
GOOD LABORATORY PRACTICES

2. INTRODUCTION TO GLP
Definition:
GLP may be defined as a body rules, operating
procedures, and practices established by a given
organization, that are considered to be mandatory with a
view to ensuring quality and correctness in the results
produced by a laboratory.
OR
GLP is a quality system concerned with the
organizational process and conditions under which non-
clinical health and environmental safety studies are
planned, performed, monitored, recorded, archived and
reported.

3. HISTORY OF GLP
 GLP was first introduced in New Zealand and
Denmark in 1972, and later in the US in 1978 in
response to the ”Industrial BioTest Labs” scandal.
 It was followed a few years later by the
Organization for Economic Co-operation and
Development (OECD) Principles of GLP in 1992;
the OECD has since helped promulgate GLP to many
countries.

4. ELEMENTS OF GLP

5. STANDARD OPERATING PROCEDURE (SOP)
Usually provide an elaborated description of various on-
going activities carried out Analytical laboratory.
Examples:
Sample handling and preparation
Analytical method used
Proper maintenance of all instruments
Record keeping.

6. QUALITY ASSURANCE UNIT (QAU)
QAU is entirely responsible for assuring GLP being
implemented effectively.
The prime responsibilities that are exclusively fall within
the domain of QAU are -
oImplementation of quality procedures.
oAssessment of quality procedures on a continual basis.
oAudits of the laboratory periodically.

7. OBJECTIVES OF GLP
 Adopt good and safe operating procedures and
recording systems.
 Prevent human errors in the performance of the
job.
 Prevent equipment errors in measurements.
 Prevent unsafe and hazardous acts which could
affect individuals and/or properly.
 Improve efficient performance of the job.

9. THE IDEA BEHIND GLP
It belongs to the functions of the respective
authorities to make sure that the safety and the
environment is proven safety claims can be verified.
 A regulatory authority may then obtain verification of
such an experimental result by either two ways.
1. It self
2. Step-by-step

10. CONTINUE…
The GLP principles are designed as a tool
enabling also the improvement of study and data
quality .
All these requirements can be summarized in three
issues that are central to the ideas behind GLP.
Possibility
Accountability
GLP increases awareness.

11. CONTINUE…
1. POSSIBILITY:
To reconstruct the whole course of a safety study, even years
after it has been performed and even in the absence of
persons having been actively involved in the conduct of this
specific study.
Ex: All the animals have received the correct dose of the test
item at all times, that the correct samples have been taken and
analyzed, and the actual data that had been collected.
These report submitted to the Regulatory Authority.

12. CONTINUE…
2.ACCOUNTABILITY
It is very closely connected with the first one. The
documentation needed in the GLP compliant conduct of a
study will tell years later who was doing what, and who
could be held accountable for mistakes.
3.GLP INCREASE AWARENESS
It awareness of management for the never ending task to
strive for optimal quality and transparency of the studies
conducted at their test facilities of study directors for the
orderly performance of the studies they are to control.

13. SCOPE OF GLP
 The scope of GLP as it is defined in the OECD Principles,
and which states that GLP encompasses:
“the non-clinical safety testing of test items contained in
pharmaceutical products, pesticide products, cosmetic products,
veterinary drugs as well as food additives, feed additives, and
industrial chemicals. These test items are frequently synthetic
chemicals, but may be of natural or biological origin and, in
some circumstances, may be living organisms.
 The purpose of testing these test items is to obtain data on
their properties and/or their safety with respect to human
health and/or the environment.” (OECD, 1998).

14. THE AREAS OF APPLICATION
 GLP is applicable to safety studies in two major areas:
1. Effects on human health
2. Effects on the environment
 These two areas may share some types of studies that
have to be conducted in order to test the safety of the
respective test item, but other study types may exclusively
be required for one or the other area.
 The second point to be observed in the judgment on the
necessity for GLP adherence is that these studies are not
only conducted to “obtain data on properties and/or its
safety”, but that they are “intended for submission to
appropriate regulatory authorities”.

15. CONTINUE…
The applicability of GLP to “human health and environmental
safety” testing spells out yet another facet of this delimitation which
may give rise to a number of questions. Laboratory testing that is
performed in a non safety-related way.
Example:
The physical-chemical parameters of a pharmaceutical chemical
substance might thus not be considered as related to an assessment
of human health risks. For a pesticide or another environmental
substance, however, parameters like their vapour pressure, their
acid-base equilibrium constant or their water/octanol partition
coefficient, all of which will determine the nature and extent of
environmental dissipation, and accumulation, will certainly be
safety-related data that have to be generated under GLP.

16. CONTINUE…
 The data to be generated under GLP have to have a connection
to the assessment of safety for either of the two fields of
human health or for the environment. In this regard there
are apparent differences between these two fields.
 The necessity to follow the strict regulations of GLP will be
determined by the two basic principles of the scope of GLP –
the safety-relatedness of the investigation and the
foreseeable submission to an Regulatory Authority – the
interpretation of which may, however, under different
circumstances lead to different answers and conclusions.

17. THE PILLARS OF GOOD LABORATORY PRACTICES
Good Laboratory Practice is based on four pillars
which have to support the implementation and daily
observance of its Principles:
The Management
The Quality Assurance
The Study Director
The National Compliance Monitoring Authority

18. THE MANAGEMENT
 A management which is convinced that GLP is a
good thing in itself.
 Therefore, an essential management responsibility is
the appointment and effective organization of an
adequate number of appropriately qualified and
experienced staff throughout the facility, including
those specifically required to perform QA functions.
 And this management responsibility brings us to the
second pillar of Good Laboratory Practice.

19. THE QUALITY ASSURANCE
The second pillar of this building, named GLP, is the Quality
Assurance, an internal system for ensuring that the Principles of
GLP are observed.
 The compliance with the GLP standards in the everyday work
at a test facility can only be as good as the critical
observational capability of the Quality Assurance inspector
on the one hand, and also only as good as the ability of the
Quality Assurance manager to succeed in carrying through
any objections to the way GLP is handled by individual
persons.
 Quality Assurance may thus be regarded as the prolonged arm
of management, which exercises its control over the GLP
compliance within the test facility.

20. THE STUDY DIRECTOR
The third pillar of the GLP system consists of
one single person! The Study Director is the one
single point of study control and the one single
person on whom the whole study hinges from the
beginning to the end.
The Study Director is usually the scientist
responsible for study plan design and approval,
as well as for overseeing data collection, analysis
and reporting, and for drawing the final overall
conclusions from the study.

22. NATIONAL COMPLIANCE MONITORING AUTHORITY
 It is the National Compliance Monitoring Authority for the
international recognition and mutual acceptance of studies and
test data.
 This Recommendation sets out the basic characteristics of the
procedures for monitoring compliance with the GLP
Principles, and following this Recommendation two guidance
documents on “Compliance Monitoring Procedures for
GLP” and on the “Conduct of Laboratory Inspections and
Study Audits”, both directed at the National Monitoring
Authorities, were issued.
 This fourth pillar of GLP is the comparability of the
monitoring procedures, mutual trust is achieved and the
mutual acceptance of safety test data will be possible.

23. WHERE CAN GLP BE PROFITABLY APPLIED…?
 The term “Good Laboratory Practice” is restricted to
apply to such test facilities only, which are performing
“human health and environmental safety studies”, studies
which furthermore have to be submitted to a Regulatory
Agency for assessment. It is evident that not every
laboratory would fulfil these conditions.
 Outside the field of “non-clinical human health and
environmental safety” testing, where GLP has to apply,
official recognition should be based on quality standards
other than GLP, since GLP is absolutely confined to the
said area.

24. PRINCIPLES OF GLP
The important principles are not new, nor are they unknown; they
can be summarized as follows:
 There should be a unique identification for the study and all of its
parts.
 All original observations in a study should be immediately, clearly
and legibly recorded.
 All records should be in the form of bound notebooks or on
continuously numbered sheets.
 All entries and corrections to them should be dated and initialed.
 Records related to the test system itself should be gathered and
retained.
 Specimens should be clearly identified so as to allow full
traceability.
 At the end of a study, all raw data should be assembled, catalogued
and archived.

25. CONTINUE…
The GLP Principles are much more demanding in
this respect, and in the section on the “Conduct of
the Study”, the following instructions are given for
the recording of data:
 All data generated during the conduct of the
study should be recorded directly, promptly,
accurately, and legibly by the individual entering
the data. These entries should be signed or initialed
and dated.

26. CONTINUE…
 The possibilities inherent in the applicable
control mechanisms might subsequently provide
the means for judging the shortcomings of the
present activities and for improving the scientific
quality of the future work.

27. REFERENCES
 Good Laboratory Practice – the Why and
the How by Jürg P. Seiler

28. THANK
YOU....