OECD Good Laboratory Practice and ISO/IEC 17025:

GLP Compliance Monitoring and Laboratory Accreditation

1. Introduction

An effective comparison between the OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC
17025: General requirements for the competence of testing and calibration laboratories (and between the
associated mechanisms for formal recognition of compliance or conformity; namely GLP Compliance
Monitoring and laboratory accreditation) can only be made when historical origins and objectives of the two
documents are considered.

This document sets out to explain these often philosophical differences and is not intended to be a detailed
nor exhaustive comparison of the technical content of the two documents. In many respects, such a
comparison is counter-productive to the understanding of the application of the two documents and when
deciding which quality assurance system is most applicable in a given situation.

The comparison of GLP vs. ISO/IEC 17025 and of GLP Compliance Monitoring vs. laboratory accreditation
are closely linked but for clarity are considered separately in the document.

2. Comparison of, and differences between, GLP and ISO/IEC 17025

Introduction and History

Good laboratory practices were developed in the 1970s in response to fraudulent scientific safety studies
being submitted to regulatory authorities in support of applications for the regulatory registration/approval
of chemicals. They were developed by governments as a regulatory control mechanism for industry, to
ensure such future safety studies would be of acceptable quality and integrity. An internationally
harmonised set of good laboratory practices were developed by the OECD and published in 1981 as the
OECD Principles of Good Laboratory Practice.

As a regulatory control mechanism, GLP compliance is written into law in many countries; not only as a
legal requirement that non-clinical health and environmental safety studies intended for regulatory
submission be conducted under GLP, but also the text of the GLP requirements themselves are written
into Acts, Regulations, Directives or the like. In some cases, it is illegal to conduct such studies that are not
in compliance with GLP.

GLP originated from and remains as an integral part of the regulatory sector.

ISO/IEC 17025 has developed out of the testing/calibration laboratory and laboratory accreditation
communities rather than the regulatory sector. Originally published as ISO Guide 25:1990, its origins came
from the laboratory accreditation community as a mutually agreed set of criteria that a laboratory should
fulfil in order to demonstrate its competence. It is a voluntary standard in the sense that laboratories
choose whether to operate in accordance with its requirements, but they do need to demonstrate
conformity should they seek third party recognition of their competence to perform their tests/calibrations.
As with all standards published by the International Standards Organisation (ISO), it is written, approved,
and published by national standards bodies who are members of ISO, not by governments as part of their
development of domestic legal instruments.

While governments may choose to recognise the value of international standards such as ISO/IEC 17025,
and are increasingly adopting them as an effective tool to meet regulatory objectives, ISO/IEC 17025 is still
fundamentally a voluntary sector standard.

Application

The OECD Principles of Good Laboratory Practice are a set of principles that define a quality system to be
applied to the conduct of non-clinical health and environmental safety testing intended for submission to
appropriate regulatory authorities in support of the registration, licensing or regulation of chemical and
related products. They are therefore quite specific in their intended application GLP is not intended nor
required for non-regulated testing.

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For the non-clinical health and environmental safety testing that is regulated and is required to be
conducted under GLP, the testing is often scientifically multi-disciplinary and individual tests may be
conducted over several months. For example, traditionally, GLP has been applied to toxicological testing
using laboratory animals. Long term toxicology studies may run for several months and involve may
scientific disciplines such as analytical and bio-analytical chemistry, clinical pathology testing,
histopathology, physical testing and the like. Each study will generally involve a new chemical under test
and thus the individual assays within each study will vary from study to study, and may never be used
again when the suite of testing is completed. Likewise, regulatory non-clinical health and environmental
safety studies may be conducted outside of a traditional laboratory setting such as in the field and in
greenhouses. The OECD Principles of Good Laboratory Practice are therefore, out of necessity, quite
general in their requirements (a set of principles) to accommodate the wide variety of studies undertaken,
the scientific disciplines with each, and variability within studies for different chemicals under test. The
focus of GLP is on the individual study, a discrete package of work passing through the test facility and
being conducted in accordance with a Study Plan, culminating in a single study report.

ISO/IEC 17025 is a management system standard specific to defining the requirements for the
competence of testing and calibration laboratories. For the purposes of this discussion, the application of
ISO/IEC 17025 will be restricted to testing laboratories. It is intended to be applied to laboratories that
conduct the same assays on a regular basis according to defined methodology. The type of samples
tested and the type of test methods employed vary little from day to day. The focus of ISO/IEC 17025 is
therefore on the systems within the laboratory which support and provide critical input into these standard
assays. Such inputs are often unchanging and thus ISO/IEC 17025 may be quite prescriptive in its
requirements. ISO/IEC 17025 is generally adopted by laboratories receiving a continual stream of samples
of a similar nature, being tested to unchanged test methods within a limited range of scientific disciplines,
and producing a continual stream of individual test results.

There are certain types of regulated non-clinical health and environmental safety testing that could be
effectively conducted under an ISO/IEC 17025 management system, typically physical / chemical tests to
determine these properties for a regulated chemical product. These are normally tests of short duration
using standard testing methods and laboratory techniques within the limited range of physical and
chemical testing. And, although the ISO/IEC 17025 management system may be suitable for such testing,
this does not imply that such testing would comply with the requirements of the Principles.

For the majority of regulated non-clinical health and environmental safety testing, the ISO/IEC 17025
management system standard is not well suited to ensure the quality and integrity of such studies is
maintained. The variability inherent in such studies arising from living test systems; from the scientific
multi-disciplinary nature of the studies; often from the multi-site nature of such studies; and from the
differences in the chemical product under test in each study mean the application of ISO/IEC 17025 to the
conduct of the testing becomes very difficult. The OECD Principles of Good Laboratory Practice on the
other hand have been specifically designed to accommodate the management of such variability.
Furthermore, the requirements of GLP and ISO/IEC 17025 differ: for instance, GLP has more specific
requirements with regard to quality assurance activities and the role of the Study Director with overall
responsibility for all phases of the study, while it does not have any requirements on handling complaints
from the test facilitys customers, as in ISO/IEC 17025.

3. Comparison of, and differences between, GLP Compliance Monitoring and laboratory
accreditation against ISO/IEC 17025

Introduction and History

With the introduction in the 1970s of good laboratory practices into the regulated sector as a regulatory
control mechanism, governments needed to introduce mechanisms to ensure the enforcement of the new
GLP compliance requirements for regulatory non-clinical health and environmental safety testing.
Governmental, or government approved, GLP Compliance Monitoring inspectorates were thus established.
These inspectorates conduct inspections of test facilities to ensure such studies are conducted in
accordance with the national GLP regulations. This will include inspections of individual studies that have
been submitted to regulatory authorities to verify that these particular studies have been conducted in
accordance with GLP within the test facility. GLP Compliance Monitoring is thus a regulatory inspection
process to verify compliance with the relevant laws pertaining to GLP, and it is the regulatory/receiving
authorities who have most interest in the outcome of GLP Compliance Monitoring inspections for they

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need the assurance of the quality and integrity of the test data in order to make valid regulatory risk
assessment decisions.

Laboratory accreditation also commenced on an international scale in the 1970s, driven by the laboratory
community wishing to obtain third party independent recognition (accreditation) of their competence, either
for their own assurance or to demonstrate the same to their customers. Laboratory accreditation was
borne out of and operated in the voluntary (non-regulatory) sector. Each national accreditation body
developed their own criteria for accreditation until the publication of the internationally agreed criteria in
ISO Guide 25:1990 described above.

Application

Laboratory accreditation recognises a laboratorys competence to carry out specific tests, and the scope of
a laboratorys accreditation is made up of lists of these tests that have been assessed by the accreditation
body and for which the laboratory has been judged to be competent to perform. The cornerstone of the
laboratory accreditation process is that technical competence to perform any particular test has to be
demonstrated to an assessor who is a technical peer of the laboratory. The scientific and technical validity
of the laboratorys test results has to be demonstrated to the accreditation body to be valid. The application
of this concept to the majority of non-clinical health and environmental safety studies would be problematic
and impractical, in that each and every study conducted is likely to be needed to be assessed by the
accreditation body given the variability in study design and content of such studies.

For regulated testing under a GLP system, the responsibility for evaluating the technical validity of a study
(study design) and validity of the conclusions drawn from the study results lies with the regulatory reviewer.
But this evaluation can only be effective if the study data can be relied upon; that the quality and scientific
integrity of the data can be demonstrated and the conduct of the study reconstructed. A GLP quality
system is designed specifically to this end, for the entire study, with a focus on the administration and
management of the conduct of the study, rather than the science of the study being undertaken.

4. Summary

While the OECD Principles of Good Laboratory Practice and ISO/IEC 17025 both set out the requirements
for quality systems under which testing is conducted, they are, as a result of their evolution and history,
documents with a different purpose. It is impractical, and in many cases, would be ineffective to apply one
of the set of requirements with the intent of meeting the others purpose.

The OECD Principles of Good Laboratory Practice is used as a regulatory control mechanism to assure
the quality and integrity of non-clinical health and environmental safety studies regulated under law. Such
testing, for the most part, is complex and variable, and the OECD Principles of Good Laboratory Practice
are specifically designed, as a set of principles to be applied to individual studies, to accommodate the
complexity and variability of such studies.

ISO/IEC 17025 is a voluntary sector standard, intended to be applied to testing laboratory facilities
conducting individual assays according to established methodology with little variability. The focus of the
standard is on the on-going operation of the laboratory itself, rather than on the specific conduct of a test
and can be applied to any testing laboratory in any scientific discipline.

GLP Compliance Monitoring is a regulatory inspection with the intent of verifying that individual non-clinical
health and environmental studies submitted to receiving authorities for the purpose of registration/approval
of chemical products meet the requirements of the law i.e. that the study has been conducted in
accordance with the national GLP regulations. The focus of such inspections is on the studies conducted,
where audits of individual studies make a significant component of the inspection. The main customer of
GLP compliance monitoring inspections is the receiving authorities to which the studies have been
submitted.

Laboratory accreditation is fundamentally a voluntary sector service providing third party, independent
recognition of competence of testing laboratories operating in accordance with ISO/IEC 17025. It is
restricted to recognising a laboratorys competence to conduct individual assays on a defined range of
sample types using defined methodology. While laboratory accreditation services are increasingly being
used by governments to meet regulatory and trade objectives, these have not been applied to non-clinical

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health and environmental safety testing because ISO/IEC 17025 is not considered the most appropriate
tool for an effective regulatory control mechanism for this type of work.

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