Date: Issue 5, 10 February 2021

STANDARDS MALAYSIA Date of 1st Issue: 29 July 2009

GOOD LABORATORY Amendment No.: --
PRACTICE COMPLIANCE
PROGRAMME
Date Amended: --
(GLP CP) MANUAL

Department of Standards Malaysia

Menara Cyber Axis
Level 4, 5, 6 & 7, Tower 2, Cyber 6
Jalan Impact
63000 Cyberjaya, Selangor, Malaysia
Tel: +(603) 8008 2819/ 2817/ 2821 Fax : +(603) 8008 2901
Website: http://www.jsm.gov.my

Reviewed by: Approved by:

WAN RUKIMAN WAN MAMAT SHAHARUL SADRI BIN ALWI

Director of Accreditation Director General
Department of Standards Malaysia Department of Standards Malaysia

Date: 8 February 2021 Date: 10 February 2021

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Date of 1st Issue: 29 July 2009
GOOD LABORATORY Amendment No.: --
PRACTICE COMPLIANCE
PROGRAMME
Date Amended: --
(GLP CP) MANUAL

Table of Contents

1. Introduction 1
2. Objective 1
3. Scope 2
4. Terms and Definition 3
4.1 Good Laboratory Practice 3
4.2 Terms Concerning the Organisation of a Test Facility 3
4.3 Terms Concerning the Non-Clinical Health and Environment Safety Study 4
4.4 Terms Concerning the Test Item 5
4.5 Terms Concerning to Compliance Programme 6
5. GLP Compliance Monitoring Authority (CMA) 7
5.1 Administration 7
5.2 Confidentiality 9
5.3 Personnel and Training 10
6. GLP Compliance Programme (GLP CP) 12
6.1 General 12
6.2 Mechanism of entering into the programme 13
6.3 Categories of Test Facility Inspection/ Study Audit 14
6.4 Fees 17
7. Follow up to Test Facility Inspections and Study Audits 18
7.1 Inspection report 18
7.2 Classification of Deviation 18
7.3 Final approval of inspection report 19
7.4 Status of GLP Compliance 19
8. GLP Compliant Symbol 20
9. Rights and Duties 21
10. Complaint/Appeal Procedures 22
11. Archives 23
12. References 24
13. List of Appendixes 26
14. List of Forms 27
15. Acronym 28

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Date of 1st Issue: 29 July 2009
GOOD LABORATORY Amendment No.: --
PRACTICE COMPLIANCE
PROGRAMME
Date Amended: --
(GLP CP) MANUAL

1.0 INTRODUCTION

The manual describes the quality management system of the Department of

Standards Malaysia (Standards Malaysia) as one of the National Compliance
Monitoring Authority (CMA) for monitoring compliance to Organisation for
Economic Co-operation and Development (OECD) Principles of Good
Laboratory Practice (GLP). This manual is supplemented by relevant forms,
OECD documents and existing procedures based on MS ISO/IEC 17011.

Based on Cabinet Paper dated 13 February 2008, the Cabinet has approved
the following:

i) Ministry of Health Malaysia is the coordinator for Good Laboratory

Practice Compliance Monitoring Programme (CMP) in Malaysia.

ii) Two Compliance Monitoring Authorities (CMAs) were appointed by the

Government of Malaysia:
(a) National Pharmaceutical Control Bureau (NPCB), Ministry of Health
Malaysia and
(b) Department of Standards Malaysia, Ministry of Science, Technology
and Innovation.

2.0 OBJECTIVE

The objectives of this manual are to explain the following:

a) Policies and procedures of Standards Malaysia for GLP Compliance

Programme (GLP CP);

b) Mechanism for Test Facilities entering into the GLP CP;

c) Process on the conduct of Inspection on Test Facilities and Study

Audit;

d) Process of exchanging information with other national CMA according

to the provisions of OECD GLP and

e) Reporting of the Inspection and Study Audit.

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3.0 SCOPE

GLP CP is a voluntary programme offer to test facilities conducting studies for

non-clinical health and environmental safety studies, for the purpose of
registering and/or licensing on test item contained in products of the following
categories:

i. Industrial chemicals
ii. Pesticides
iii. Feed additives
iv. Biotechnology (non-pharmaceutical)
v. Others (such as nanomaterials, biocide, schedule waste, plant
protection)

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 the non-clinical safety testing of test items is to obtain data on their
properties and/or their safety with respect to human health and the
environment. Non-clinical health and environment safety studies covered by
the Principles of Good Laboratory Practice include work conducted in the
laboratory, in greenhouses and in the field.

Type of studies/areas of expertise on test items subjected to Standards

Malaysia GLP CP are in the following categories:

1) physical-chemical testing
2) toxicity studies
3) mutagenicity studies
4) environmental toxicity studies on aquatic and terrestrial organisms
5) studies on behavior in water, soil and air; bioaccumulation
6) residue studies
7) studies on effects on mesocosms and natural ecosystems
8) analytical and clinical chemistry testing
9) other studies (such as biological efficacy)

Note: Test facility conducting studies on pharmaceutical, cosmetics, veterinary, food additives
and medical device products, will be inspected by the National Pharmaceutical
Regulatory Agency (NPRA), Ministry of Health (http://npra.gov.my.)

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4.0 TERMS AND DEFINITIONS

The manual was prepared based on current documents of OECD Series on

Principles of Good Laboratory Practice and Compliance Monitoring. These
documents are regularly reviewed; therefore, the user of this manual should
also refer to the OECD for updated version. In cases where contradictory
interpretation or elaboration arises between this manual and OECD series,
the OECD series would be considered as final.

Whenever new documents are published by the OECD relevant to Good

Laboratory Practice, they should be read and complied accordingly.

4.1 Good Laboratory Practice (GLP)

GLP is a 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.

4.2 Terms concerning the organisation of a Test Facility

a. Test Facility means the persons, premises and operational unit(s) that
are necessary for conducting the non-clinical health and environmental
safety study. For multi-site studies, those that are conducted at more
than one site, the test facility comprises the site at which the Study
Director is located and all individual test sites, which individually or
collectively can be considered to test facilities.

b. Test Site means the location(s) at which a phase(s) of a study is

conducted.

c. Test Facility Management means the person(s) who has the authority
and formal responsibility for the organisation and functioning of the test
facility according to these Principles of Good Laboratory Practice.

Test Site Management (if appointed) means the person(s) responsible

for ensuring that the phase(s) of the study, for which he is responsible,
are conducted according to these Principles of Good Laboratory
Practice.

d. Sponsor means an entity which commissions, supports and/or submits a

non-clinical health and environmental safety study.

e. Study Director means the individual response for the overall conduct of
the non-clinical health and environmental safety study.

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f. Principle Investigator means an individual who, for a multi-site study,

acts on behalf of the Study Director and has defined responsibility for
delegated phases of the study. The Study Director’s responsibility for the
overall conduct of the study cannot be delegated to the Principal
Investigator(s); this includes approval of the study plan and its
amendments, approval of the final report, and ensuring that all applicable
Principles of Good Laboratory Practice are followed.

g. Quality Assurance Programme means a defined system, including

personnel, which is independent of study conduct and is designed to
assure Test Facility Management of compliance with these Principles of
Good Laboratory Practice.

h. Standard Operating Procedures means documented procedures,

which describes how to perform tests or activities normally not specified
in detailed in the study plan of test guidelines.

i. Master Schedule means a compilation of information to assist in the

assessment of workload and for tracking of studies at a test facility.

4.3 Terms Concerning the Non-Clinical Health and Environment Safety

Study
a. Non-clinical and environmental safety study, henceforth referred to
simply as ‘study’, means an experiment or set of experiments in which a
test item is examined under laboratory conditions or in the environment
to obtain data on its properties and/or safety, intended for submission to
appropriate regulatory authorities.

b. Short-term study means a study of short duration with widely used

routine techniques.
*Short-term physical/chemical studies are those studies, tests,
measurements or observations which are of a short duration (less than
one week), employ widely used techniques and yield easily repeatable
results, often expressed by simple numerical values or verbal
expressions.
Example of short-term biological studies are skin absorption tests,
bacterial mutagenicity studies, acute ecotoxicological studies, in vitro and
ex vivo studies and some metabolism studies.

c. Study plan means a document, which defines the objectives and

experimental design for the conduct of the study and includes any
amendments.

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d. Study plan amendments mean an intended change to the study after

the study initiation date.

e. Study plan deviation means an unintended departure from the study

plan after the study initiation date.

f. Test system means any biological, chemical or physical system or a

combination thereof used in a study.

g. Raw data means all originally test facility records and documentation, or
verified copies thereof, which are the result of the original observations
and activities in a study. Raw data also may include, for example,
photographs, microfilm or microfiche copies, computer readable media,
dictated observations, recorded data from automated instruments, or any
other data storage medium that has been recognised as capable of
providing secure storage of information for a time period.

h. Specimen means any material derived from a test system for

examination, analysis, or retention.

i. Experimental starting date means the date on which the first study
specific data are collected.

j. Experiment completion date means the last date on which data are
collected from the study.

k. Study initiation means the date the Study Director signs the study plan.

l. Study completion date means the date the Study Director signs the
final report.

4.4 Terms Concerning the Test Item

a. Test item means an article that is the subject of a study.

b. Reference item (control item) means any article used to provide a

basis for comparison with the test item.

c. Batch means a specific quantity or lot of a test item or reference item

produced during a defined cycle of manufacture in such a way that it
could be expected to be of a uniform character and should be designated
as such.

d. Vehicle means any agent, which serves as a carrier used to mix,

disperse, or solubilise the test item or reference item to facilitate the
administration/application to the test system.

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e. Software: A program required for or developed, adapted or tailored to

the test facility requirements for the purpose of controlling processes,
data collection, data manipulation, data reporting and/or archiving.

f. Source code: An original computer program expressed in human-

readable form (programming language), which must be translated into
machine-readable form before it can be executed by the computer.

g. Validation of computerised system: Action of proving that a process

leads to the expected result. Validation of a computerised system
requires ensuring and demonstrating the fitness of its purpose.

4.5 Terms concerning to Compliance Programme

a. GLP Principles: Principles of Good Laboratory Practice that are

consistent with the OECD Principles of Good Laboratory Practice

b. GLP Compliance Monitoring: The periodic inspection of test facilities

and/or auditing of studies for the purpose of verifying adherence to GLP
Principles.

c. (National) GLP Compliance Programme: The particular scheme

established by a Member country to monitor good laboratory practice
compliance by test facilities within its territories, by means of inspections
and study audits.

d. (National) GLP Monitoring Authority: A body established within a

Member country with responsibility for monitoring the good laboratory
practice compliance of test facilities within its territories and for
discharging other such function related to the good laboratory practice as
may be nationally determined. It is understood that more than one such
body may be established in a Member country.

e. Test Facility Inspection: An on-site examination of the test facility’s

procedures and practices to assess the degree of compliance with GLP
Principles. During inspection, the management structures and
operational procedures of test facility are examined, key technical
personnel are interviewed, and the quality and integrity of data generated
by test facility are assessed and reported.

f. Study Audit: A comparison of raw data and associated records with the
interim or final report in order to determine whether the raw data have
been accurately reported, to determined whether testing was carried out
in accordance with the study plan and Standard Operating Procedures,
to obtain additional information not provided in the report, and to
established whether practices were employed in the development of data
that would impair their validity.
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g. Lead Inspector: A person who has been trained on OECD Principles of

GLP, to lead and responsible for the inspection conducted.

h. Inspector: A person who performs the Test Facility Inspections and

Study Audits on behalf of Standards Malaysia.

i. Expert: A person who has knowledge in their specified area i.e

computerised system, toxicology etc

j. GLP Compliance Status: The level of adherence of a test facility to the

GLP Principles as assessed by the (National) GLP Monitoring Authority.

k. Regulatory Authority: A national body with legal responsibility for

aspects of the control of chemicals.

5.0 GLP COMPLIANCE MONITORING AUTHORITY (CMA)

Standards Malaysia is one of the CMAs appointed by the Government of

Malaysia on 13 February 2008 for the products as mentioned in the scope.
The Director General of Standards Malaysia is responsible for GLP CP and its
GLP Unit under Accreditation Division carries out the daily operations.

5.1 Administration

Standards Malaysia was set up by the Government of Malaysia on 28 August

1996 under an Act of Parliament, the Standards of Malaysia Act 1996 (Act
549) and Amendment 2012 (Act A1425). It was placed under the Ministry of
Science, Technology and Innovation (MOSTI) until 16 October 2018 and
transferred to Ministry of International Trade and Industry (MITI) since then.
Standards Malaysia is a government funded agency, operates as the sole
national accreditation body in the country for conformity assessment activities.
Details on the establishment of Standards Malaysia, its roles and objectives
as an independent body, including its advisory council and committees are
described in the document RoP-MSAC and other related documentations.

The office address and further information on Standards Malaysia GLP CP

can be obtained from:

Director General
Department of Standards Malaysia
Menara Cyber Axis
Level 4-7, Tower 2, Jalan Impact
Cyber 6, 63000 Cyberjaya, Selangor, Malaysia
Tel : +(603) 8008 2819/ 2817/ 2821 Fax : +(603) 8008 2901
Website: http://www.jsm.gov.my
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As GLP CMA, Standards Malaysia has adopted the OECD Principles GLP in
its structure, policies and procedures to ensure implementation of GLP CP is
administered in an independent and impartial manner.

Cooperation with other GLP CMA may include, carrying out inspections of test
facility/study audit on the request of local/international Regulatory Authority
and foreign GLP CMA.

Standards Malaysia is directly responsible for an adequate team of inspectors

having the necessary technical/scientific expertise or is ultimately responsible for
such a “team”. Details are described in the personnel and training section of the
manual.

5.1.1 Structure of Organisation

Director General of Standards Malaysia as the head of department who is

appointed in accordance with Section 9 and responsible to oversee the overall
operation and executive functions of the department as stipulated in
Subsection 10 of the Act 549 and reports to the Minister of MITI through the
Secretary General of the Ministry. In performing his duties, he is assisted by
one (1) Senior Director and three (3) Directors.

The Director of Accreditation is responsible for overseeing the operation of all

accreditation and GLP CP including regional and international accreditation /
compliance matters. The organisation chart of the Accreditation Division and
GLP Unit are as shown in (Appendix 1) and (Appendix 2) respectively.

5.1.2 Malaysian Standards and Accreditation Council

The Malaysian Standards and Accreditation Council (MSAC or the Council) is

an independent advisory council who advises the Minister and approves all
accreditation schemes, criteria and programmes. The terms of reference,
memberships and rules of procedure of MSAC are described in document
RoP-MSAC.

5.1.3 National Accreditation Committee (NAC)

The NAC is established by the MSAC and has been delegated by the MSAC
to perform specific functions relating to accreditation and GLP compliance,
and to make recommendations on specific matters to the MSAC. The terms
of reference, memberships and rules of procedure of NAC are described in
the document RoP-NAC.

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5.2 Confidentiality

Standards Malaysia procedures provide adequate arrangement consistent with

the laws of Malaysia, to safeguard confidentiality of the information obtained
during its compliance monitoring activities at all levels within the organisation.
This arrangement is to safeguard confidentiality which all members of the
MSAC, NAC, Inspectors/Experts, Appeal Panels, Technical Working Groups
and individuals acting on behalf of Standards Malaysia.

During an inspection, Standards Malaysia inspectors/experts would have

access to confidential information relating to individual test facilities activities
and practices. Except where required by law or permitted by contractual
arrangements, the findings of any inspection must be treated as confidential.

Inspectors/experts, observers, staff and individual acting on behalf of

Standards Malaysia and members of the MSAC, NAC, Inspectors/Experts,
Appeal Panels, TWG and all to whom that have access to Standards Malaysia
files or test facility files, shall be required to sign an Undertaking for
Maintaining Confidentiality, Impartiality and Declaration of No Conflict of
Interest. In addition, all inspectors/experts shall abide by the GLP-R005:
Code of Ethics for Inspectors (Appendix 4) that includes the upholding of
confidentiality requirements.

Information about a test facility shall not be disclosed to a third party without
written consent of the test facility in question. Where the law requires
information to be disclosed to a third party, the test facility shall be informed
accordingly subject to the advice of Standards Malaysia or Regulatory
Authority where applicable. However, Standards Malaysia shall be required to
inform OECD on the GLP status of test facilities and any non-compliant GLP
studies. In such cases the written consent of the test facilities shall not be
required. This applies to study audit /facilities inspection conducted on the
request of national/international authority.
The Government General Orders and the Official Secret Act provide that any
person found contravening the above requirements is guilty of an offence and
on conviction is liable to a fine, or to imprisonment or to both.
During the Inspections and Study Audits, the inspectors may have access to
highly confidential and commercially valuable information. To ensure that
maximum confidentiality is maintained:

• Standards Malaysia has to communicate with the test facility at least

two weeks before the start of the inspection/study audit. The observers
are required to sign and date a form, GLP-R004: Undertaking of
Confidentiality (Appendix 5). Test facility may object to the use of any
inspector/expert or observers with valid reasons. The reason for
objection should be communicated to Standards Malaysia.
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• Information about the Standards Malaysia GLP CP and Directory of GLP

compliant test facilities are available on the website www.jsm.gov.my.
Confidential information such as inspection reports, questions and replies,
minutes of internal meetings, etc., which are available on paper or
electronic, can only be accessed by Standards Malaysia officers,
inspectors/experts and Regulatory Authorities concerned.

• Commercially sensitive information and about the inspections/Study Audits

undertaken in test facilities can be requested by other local/international
national Compliance Monitoring Authority and Regulatory Authority.
However, paper or electronic information is only available on request and
with the permission of the test facility.

• Copies of any documents taken from the test facility before, during and
after the inspections are uniquely marked. These document should be
listed, signed and dated by inspector and test facility representative in
standard form, GLP-P016: List of Evidence Document (Appendix 6) and
retained by test facility and CMA. The list must be verified and dated by
lead inspector/inspector.

All the original and electronic documents of the Standards Malaysia GLP CP
are stored and retained separately from other documents. Only the respective
personnel mentioned above have access to the documents maintained in
Standards Malaysia archive.

Standards Malaysia would always ensure that sensitive business information

shall never be disclosed to any third party. Its also ensure that, commercially
sensitive and confidential information will be excised from test facility inspection
and study audit reports, before made available to Regulatory Authority and
where appropriate to the test facility inspected or concerned with study audit
and/or to study sponsors.

5.3 Personnel and Training

5.3.1 Standards Malaysia should ensure that an adequate number of competent

inspectors are appointed to carry out Inspections and Study Audits. The
inspection will be led by a Lead inspector that is responsible for the conduct of
inspection, opening conference, report findings and exit conference.
Inspectors/experts assigned will perform Test Facility Inspections and Study
Audits wherever necessary. The names of the inspectors/experts and their
organisation will be maintained in Standards Malaysia inspector database.

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5.3.2 The competence of an inspector is determined based on tertiary education in

a recognised academic institution with relevant working experience and
training in GLP inspection. In addition, the candidate shall have working
experience in field of science relevant under the GLP Compliance
Programme. The candidate shall be appointed as a Trainee Inspector by the
Director of Accreditation based on recommendation by the GLP Manager
upon satisfactory evidence provided show fulfillment of the education and
working experience requirements.

5.3.3 The Trainee Inspector is to undergo a GLP Inspector training programme.

The first part of the training programme includes at least one GLP course or
workshop organised by OECD or national/international GLP Compliance
Monitoring Authority. The aim is to equip the Trainee Inspector with adequate
knowledge of the requirements and implementation as described in the
OECD GLP document series, inclusive of the principles, guidance,
consensus and test guidelines.

5.3.4 The second aim of the GLP Inspector training programme, is to equip the
Trainee Inspector with appropriate skills and attribute for conduct of GLP
inspection. The training shall be in form of observation and/or performing
inspection. A Trainee Inspector shall be considered for appointment as a
GLP Inspector after completing at least one (1) inspection of observation and
one (1) supervised inspections/ or study audits.

5.3.5 GLP Inspector can be appointed as GLP Lead Inspector if he/she has good
managerial and leadership skills in communication, planning, organising,
conducting and reporting of the inspection/study audit including dealing with
conflicts and decision-making. A GLP Inspector shall be considered for
appointment as GLP Lead Inspector, after completing at least five (5)
inspections.

5.3.6 Standards Malaysia can appoint a person to the position of GLP Inspector or
GLP Lead Inspector, without the person going through the GLP Inspector
programmes as described in respective sections above, if the person has
already attained the necessary pre-requisites, i.e. tertiary education, relevant
working experience, comprehensive knowledge in GLP documents, trained in
GLP inspection/study audit, managerial and leadership skills in auditing.

5.3.7 GLP Inspector or GLP Lead Inspector candidate to be evaluated during the
first inspection by using GLP-R008 Evaluation Report of Inspector (Appendix
7).

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5.3.8 A person is authorized to carry-out the job function of a Standards Malaysia

GLP Inspector or GLP Lead Inspector only after the appointment letter has
been signed by the GLP CP Manager.

5.3.9 The GLP Inspectors shall participate in seminars, courses, workshops,

attachments, observations etc. for continuous improvement of their
knowledge and skill related to the inspection/study audits techniques and
scientific knowledge of area of expertise of test facilities.

6.0 GLP COMPLIANCE PROGRAMME (GLP CP)

6.1 General

Standards Malaysia GLP Compliance Programme is intended to ascertain

whether Test Facilities have implemented requirements as described in
documents of OECD Series on Principles of Good Laboratory Practice and
Compliance Monitoring according to the Malaysian legal framework. The GLP
CP includes Pre-Inspection, Inspection, Surveillance Inspection and
Extra Ordinary Inspections (where applicable). The inspection process is
demonstrated in the flow chart as in (Appendix 3).

Standards Malaysia will conduct Test Facilities Inspections/Study Audit for

compliant Test Facilities annually for the first two years and continue
Surveillance Inspection every two years in accordance with the GLP-R001:
Master Register of GLP Compliance Programme (Appendix 8).

If there is no GLP study has been conducted within two years since the last
inspection by the compliant Test Facilty, a suspension status for maximum
twelve (12) months will be given. If there is no action taken by the test facility,
Standards Malaysia will remove the test facilities from GLP CP. Test Facility
should advise Standards Malaysia as soon as possible, if there is GLP study
to be performed. Hence, Standards Malaysia will conduct Test Facility
Inspection/Study Audit in order to reinstate the suspension status.

Standards Malaysia may also remove test facilities from the GLP CP in the
light of:
i) Failure to comply with GLP CP requirements as stated in this
manual;
ii) Failure to provide cooperation or facilities for Standards
Malaysia, its inspectors and/or its authorised representatives to
discharge their official duties;
iii) Fraudulent practices, which include but not limited to; deception
of claims and alteration of GLP certificate;
iv) An individual or sole proprietorship test facilities is declared
bankrupt or enter into composition with his creditors; or

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v) Compliant test facilities, being a company, enters into

liquidation, whether compulsory or voluntary (but not including
liquidation for the purposes of reconstruction) or enters into
receivership.

Standards Malaysia shall establish and maintain a Master Register which

contains information on the name of test facility, the date of inspection, scope,
the area of studies/expertise, compliance status and remarks.

The GLP CP documents are prepared, reviewed and approved as table

below:

Type of document Prepared Reviewed Approved

Manual GLP CP GLP Personnel Director of Director
Accreditation General
Forms GLP Personnel GLP Manager Director of
Accreditation

Standards Malaysia may conduct internal audit and management review as

and when necessary together with other scheme under Accreditation Division,
with the view to ensure compliance of GLP CP with OECD requirements.

6.2 Mechanism of entering the programme

In Malaysia, GLP CP is a voluntary programme. There are two mechanisms

by which a test facility may enter the programme:

1. By submitting application (GLP-P001) to Standards Malaysia; or

2. Through request of inspection from the national or international

authority. The test facility is required to submit details information
through Standards Malaysia’s application form (GLP-P001).

In both cases the test facility details shall be registered in Standards Malaysia
Master Register.

Note: GLP-P001 Application form as in Appendix 9.

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6.3 Categories of Test Facility Inspections/Study Audits

Description of each type of inspections are as follows:

6.3.1 Pre-Inspection

Pre-inspection will be conducted within 60 days upon receiving completed

application documents including information on:

• the type, size and layout of the test facility;

• the master schedule;
• the management structure of the test facility including CVs, job
description of key personnel; and
• at least one study plan/protocol for completed study

This pre-inspection is normally carried out within one day to familiarise and to
verify that the test facility has the resources to undertake GLP studies in
respect of management structure, physical layout of buildings and type of
studies.

GLP-P004: Notification of Pre-Inspection (Appendix 10) will be sent to the test

facility before date of inspection. This notification contains inspection plan,
name of team members, date and time of Inspector’s arrival, the objective of
their visit and inspection duration. This shall allow the test facility to ensure
that the appropriate personnel and documentation are available.

In cases where particular documents or records are to be examined, it shall

be communicated to the test facility in advance of the visit so that they will be
immediately available during the Pre-Inspection. It is recommended that Test
Facility Management or its representative, Study Director, Archivist and QA
Staff be present at the Pre-Inspection.

Some areas of the test facility will be visited, whereby the overview of
activities such as the type and separation of activities, the environmental
conditions and the identification and storage of apparatus, test systems, test
and reference items and archives are observed. During this visit, the normal
work could be slightly disturbed, documents and records may be asked and
copied for inspection.

The result arising from the Pre-Inspection shall be presented in a report GLP-
P005: Pre-Inspection Report (Appendix 11). The report highlighting the gaps
will be submitted to the test facility for necessary corrective actions. The test
facility is required to submit evidence of corrective actions and accepted by
Lead Inspector before propose date of Inspection.

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Inspection is scheduled within 6 months from completion of Pre-Inspection’s

report. If the test facility is still not ready for the Inspection, Standards
Malaysia will consider performing a new Pre-Inspection or removed from the
programme.

6.3.2 Inspection

The inspection shall be a full inspection that involves both Test Facility
Inspection and Study Audit of one or more of both on-going and completed
studies on a sampling basis. This inspection would normally be conducted at
least two days depending on the number of studies conducted by test facility.
The purpose of this inspection is to verify compliance to the Principles of GLP
and Standards Malaysia GLP CP requirements.

For the purpose of this inspection, test facility is required to submit an updated
Master Schedule of all completed and on-going studies of both GLP and non-
GLP and other relevant documents to Standards Malaysia (where
appropriate). Preparation for inspection will focus on the information on the
Master Schedule for selection of the studies to be inspected.

Standards Malaysia shall notify the test facility the inspection team that has
been assigned by using GLP-P008: Notification of Inspection/Surveillance
Inspection/Extra Ordinary Inspection (Appendix 12) which normally will be
sent to the test facility before date of inspection. This notification contains
inspection plan, name of team members, date and time of Inspector’s arrival,
the objective of their visit and inspection duration.

It is absolutely necessary that Test Facility Management or its representative,

Study Director and QA staff are present at the starting conference and exit
conference. During the inspection it is desirable that a member of the QA unit
to accompany the inspectors. As far as possible, the lead inspector inspects
the general operation of the test facility whereas the Study Audit is conducted
by the inspector. During the inspections, inspectors may interview Study
Director/s, study personnel and archivist of the test facility. In some particular
cases, documents or records may be asked and copied for evidence. Test
facility shall make available a room for examination document and other
activities during the inspection.

At the starting conference, the lead inspector will introduce the inspection
team, inform the purpose, outline the scope of inspection to the Test Facility
Management and its personnel including selection of one or more on-going
and completed studies for inspection.

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The inspection team will not be concerned with the scientific design of the
study, or the interpretation of the findings of the studies, with respect to risk
for human health or the environment. These aspects are the responsibility of
those Regulatory Authorities to which the data are submitted for registration/
licensing purposes.

The inspections shall be carried out in accordance with OECD No. 3

Guidance for the conduct of Laboratory Inspections and Study Audits and
recorded in GLP-P013 Inspector Notes (Appendix 18) or GLP-P015: GLP
Inspection Checklist (Appendix 13). The criteria described in the OECD
Consensus and Advisory Documents shall also be taken into consideration
during the Test Facility Inspections and/or Study Audits, where appropriate.

During the exit conference on the last day of the inspection, the lead inspector
will present the findings in e-accreditation system or an inspection report GLP-
P009: Test Facility Inspection Report (Appendix 14) to the Test Facility
personnel and acknowledged by Test Facility Management.

6.3.3 Surveillance Inspections

First and second surveillance inspection will be conducted annually for the
first two years after the date of granting. The next surveillance inspection will
be conducted every two (2) years based on granting date. The process used
for the surveillance inspection is similar to what has been described under
inspection 6.3.2.

6.3.4 Extra Ordinary Inspections

Extra ordinary inspection shall be carried out in situation not covered under
6.3.1, 6.3.2 and 6.3.3.

The examples of such inspections are as listed below but not limited to:
• conduct of Inspection or Study Audits on the request of national or
international authority
• verification on the implementation of the corrective actions
• extension of new area of expertise
• significant changes in the test facility (e.g changes of address,
relocation, renovation etc)
• others where necessary.

The process used for the Extra Ordinary Inspection as described under
Inspection 6.3.2.

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6.3.5 Inspection conducted on the request of other authorities

Specific Study Audits may also be requested by a foreign CMA or

local/international Regulatory Authorities. Such requests may sometimes
involve Test Facility Inspections. However, it is the responsibility of the
Regulatory Authority or the foreign CMA to identify and justify the need of
such Inspections and Study Audits.

In cases where local/international Regulatory Authorities and/or foreign CMA

request for Study Audit, Standards Malaysia will invite the concerned test
facility to submit application for inspection/study audit using the GLP-P001
GLP CP Application Form (Appendix 9). The request for such audits shall be
handled as Extra Ordinary Inspection according to 6.3.4.

Test facilities should allow Standards Malaysia inspector/s access to the test
facility specify area, resources, operations, procedures, records and staff so
that the inspector/s can effectively inspect the GLP system and activities of
test facility. Detailed report of the findings will be given to the Regulatory
Authority which requested the Study Audit.

6.4 Fees

The following fees are payable by the Test Facility Management according to
Standards Malaysia Fee Regulation 2018.

Application RM 2000

Type of Inspections: Lead Inspector:

RM 1000/ man day
i) Pre-Inspection
ii) Inspection Inspector/Expert:
iii) Surveillance Inspection RM 800/ man day
iv) Extra Ordinary Inspection

Annual renewal fee RM 1000

Annual branch fee RM 500

Appeal RM 1500

Inspector/Expert from other Inspection fee, travel cost and accommodation

countries or inspection are borne by the test facility
requested by Regulatory
Authority or foreign CMA.

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7.0 FOLLOW UP TO TEST FACILITY INSPECTIONS AND STUDY AUDITS

7.1 Inspection Report

The inspection team will prepare a written report including inspection findings
via e-accreditation system or GLP-P009: Test Facility Inspection Report
(Appendix 14) and submit to the test facility after the exit conference.

7.2 Classification of Deviation

During the inspection, the inspection team may come across areas/issues
which are not in compliance with the OECD Principles of GLP, Standards
Malaysia GLP CP and Test Facility’s procedure. Such deviations are
classified into following categories.

(A) Major deviation:

Major deviation is defined as deviation from the GLP Principles, Standards

Malaysia GLP CP and Test Facility’s procedure that threatens the integrity of
quality system and/or study data.

i) When major deviation is observed during Inspection, appropriate

corrective action shall be taken by the applicant. The corrective action
period shall not exceed one (1) month from the last date of inspection,
but another delay of one (1) month can be permitted if test facility can
justify the delay. The applicant shall not receive compliance certificate
until corrective action has been handled satisfactory and accepted by
inspection team. In case if the test facility fails to take satisfactory
actions within the specified time, Standards Malaysia may consider
verification inspection or removal from the programme.

ii) When major deviation is observed during Surveillance Inspection, the

test facility would be given an opportunity to make appropriate
measures within a specified time frame of one (1) month, to resolve the
issues. If corrective action is not submitted within the time frame, the
lead inspector will make recommendation to Director General whether
part or entire part of test facility or part or entire part of study is
declared as non-compliant and remove from the program.

iii) The test facility is given 14 working days to response to the Director of
Accreditation. Once the test facility is removed from the programme,
OECD GLP secretariat will be informed about this decision according
to existing provisions of OECD and if test facility wish to re-enter into
the programme, the test facility need to submit a new application.
Standards Malaysia will consider whether it is necessary to conduct
Pre-Inspection or an Inspection can be conducted directly.
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(B) Minor deviations:

During the Inspection and/or Study Audit, the inspector may come across
deviations that have significant impact to the quality of GLP system or to
integrity of raw data. Such deviations are normally observed in isolated areas.

i) When minor deviation is observed during Inspection, appropriate

corrective action shall be taken by the applicant. The corrective action
period shall not exceed 3 months from the date of last inspection. The
applicant shall not receive compliance certificate until corrective action has
been handled satisfactory and accepted by inspection team.

ii) During the Surveillance Inspection, the test facility will be given 3 months
to take action of such deviations. However, if the test facility fails to take
satisfactory action within the duration mentioned, then Standards Malaysia
may consider removing it from the programme.

(C) Observation:

During the inspection and surveillance inspection, observations may be raised

as an opportunity for test facility to consider possible improvement.

7.3 Final approval of inspection reports

The lead inspector will review and accepts the corrective action submitted by
test facility. The inspection/study audit report will be authorised by the GLP
CP Manager and/or it will be approved by Director of Accreditation. For test
facility found to be in compliance, the Director General of Standards Malaysia
will grant/continue GLP compliance GLP-P012: Certificate of Compliance to
OECD GLP (Appendix 15) and a notification GLP-P010: Letter of Statement
of Compliance (Appendix 16) will be issued to the test facility.

For final report of specific Study Audit, a detailed report GLP-P009: Test
Facility Inspection Report (Appendix 14) approved by the Director of
Accreditation and will be provided to the requested CMA/RA, where
applicable.

7.4 Status of GLP Compliance

There will be two categories of compliance status given to test facilities

namely;
(i) in compliance [ic] and
(ii) not in compliance [nic]

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Standards Malaysia will issue a certificate with statement of GLP compliance

to show the test facility has been inspected and found to be operating in
compliance with Principles of GLP and Standards Malaysia GLP CP
requirements.

If, a test facility has been removed from the programme, it shall not make any
claim on GLP compliant.

8.0 GLP COMPLIANT SYMBOL

8.1 Any usage of this symbol or references to GLP compliant shall refer and
comply with the requirements stipulated in Accreditation Policy 1 (AP 1) –
Policy on the Use of Accreditation Symbol and Reference to Accreditation.
Test facility may use Standards Malaysia accreditation symbol or make
references to GLP compliant on promotional material (e.g. letterhead,
quotations, brochures, banners, signboards) or other items related to the test
facility GLP activity.

8.2 The symbol shall only be displayed in the appropriate form, size and colour as
detailed below:

(a) The symbol is to be displayed in colour as shown in Figure 1 or in black

and white as in Figure 2.

Figure 1: Symbol in colour

R:234 C:1%
G:40 M:97%
B:46 Y:91%
#EA282E K:0%

R:0 C:75% R:255 C:0%

G:0 M:68% G:255 M:0%
B:0 Y:67% B:255 Y:0%
#000000 K:90% #FFFFF K:0%

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Figure 2: Symbol in Black and White

R:255 C:0%
G:255 M:0%
B:255 Y:0%
#FFFFF K:0%

R:0 C:75%
G:0 M:68%
B:0 Y:67%
#000000 K:90%

(b) The GLP unique number is displayed beneath the symbol at all times as
shown in Figure 3. The words accompanying the symbol is Arial font and
bold. The size of the words is legible and proportionate to the size and
symbol.

Figure 3: Accreditation symbol with GLP number

GLP Compliant TF
GLP XXX

9.0 RIGHTS AND DUTIES

It is in the interest of the test facility to comply with the requirements of

Principles of GLP and to produce data of adequate quality for inspection and
decision-making by Regulatory Authorities. Failure to do so may lead to non-
acceptance of safety data by Regulatory Authorities.

If the Test Facility Management, QA Staff, Study Director/s, personnel and

infrastructure of the test facility, or the types of studies conducted is
significantly extended or changed, the test facility is required to inform these
changes within two weeks to Standards Malaysia.

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The acceptability of safety data is decided by the responsible

local/international Regulatory Authority and not by the Standards Malaysia. If
a study/test facility has not been performed or operating in accordance with
Principles of GLP and GLP CP requirements, Standards Malaysia will inform
OECD Secretariat through Malaysia’s coordinator (NPRA), relevant
local/international Regulatory Authority and/or foreign CMA of the receiving
country.

In order to facilitate the communication between sponsors, test facility, local/

international Regulatory Authority, OECD Secretatriat and Compliance
Monitoring Authority, Standards Malaysia will provide information on
inspections to interested parties in the following formats:

i. The conclusions of an inspection and a statement of GLP

Compliance where the inspection reveals adequate compliance with
GLP are given to the test facility. This information will also be made
available on request to the local/international Regulatory Authority
concerned;

ii. Directory of GLP Compliant Test Facility is available in our website

(http://www.jsm.gov.my);

iii. List of test facilities under Standards Malaysia GLP CP, GLP-R001:
Master Register of GLP Compliance Program (Appendix 8); and

iv. OECD Annual Overview of Test Facilities Inspected which includes

the test facilities inspected and their GLP compliance status shall
be submitted to the OECD Secretariat annually.

10.0 COMPLAINT/APPEAL PROCEDURES

Any disagreement of difference of opinion between the inspection team and

Test Facility Management arising from inspection process, will normally be
resolved during the inspection or at the exit conference. However, where
problems persist and agreement on differences cannot be reached during the
inspection process, Test Facility Management may appeal/s against the
findings. Such appeal/s against those findings must be addressed, in writing,
to the Director General of Standards Malaysia within 30 days after inspection.
The Director General of the Standards Malaysia will then take appropriate
steps to achieve a mutually acceptable resolution. Therefore, he/she may ask
for advice of an independent internal or external experts or NAC members.
Based on this advice, the Director General will make his/her final decision. As
and when required, an independent and impartial panel is established for
each appeal to be heard.

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Standards Malaysia policies and procedures for the resolution of complaints,

appeals and disputes received from customers or related matters are covered
by documents QP 110 Handling of Complaints, CAB 3 - Appeals (RoP-AP) and
CAB 2 - Complaints and other related procedures.

11.0 ARCHIVES

There are two types of documents that shall be archived:

1. Documents related to Standards Malaysia GLP CP

• The manual of Standards Malaysia GLP CP and forms

• Inspector records (such as training records, CV etc)
• Other GLP documents, if appropriate.

Standards Malaysia retains the above records at a designated area for at

least ten (10) years.

2. GLP Test Facility documents such as:

• test facility application records;
• test facility inspection records; and
• documents of correspondence with local/international Regulatory
Authority or CMA including the inspection reports etc.

All documents related to GLP test facilities are stored and retained separately
from other documents. These documents shall be retained for at least 10
years. Authorised personnel will have access to the documents maintained in
Standards Malaysia locked archive.

Test facility is recommended to retain all documents and records related to

GLP Compliance for at least 10 years. Before dispose or discard the records
or documents after 10 years, communication with sponsor need to be
recorded.

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12.0 REFERENCES

(1) Doc No. 1, OECD Principles of Good Laboratory Practice, 1998.

(2) Doc No. 2, Guidance for the GLP Monitoring Authorities Procedures for GLP,
1995.

(3) Doc No. 3, Guidance for the Conduct of Laboratory Inspections and Study
Audit, 1995.

(4) Doc No. 4, Quality Assurance and GLP, 1999.

(5) Doc No. 5, Compliance of Laboratory Suppliers with GLP Principles, 2000.

(6) Doc No. 6, The Application of the GLP Principles in field studies, 1999.

(7) Doc No. 7, The Application of the GLP Principles to short-term studies, 1999.

(8) Doc No. 8, The Role and Responsibility of the Study Director in GLP studies,
1999.

(9) Doc No. 9, Guidance for the preparation of GLP Inspection Reports, 1995.

(10) Doc No. 10, The Application of the Principles of GLP to Computerised
Systems, 1995 (withdrawn)

(11) Doc No. 11, Advisory document of panel on the GLP: Role and Responsibility
of the Sponsor in the Application of the Principles of GLP, 1998.

(12) Doc No. 12, Advisory document of panel on the GLP: Requesting and
Carrying out Inspections and Study Audits in another country, 2000.

(13) Doc No. 13, Advisory document of the Working Group on GLP: The
Application of the OECD Principles of GLP to the Organisational and
Management of Multi-Site Studies, 2002.

(14) Doc No. 14, Advisory document of the Working Group on GLP: The
Application of the OECD Principles of GLP to in-vitro studies, 2004.

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(15) Doc No. 15, Advisory document of the Working Group on GLP: Establishment
and control of Archives that Operate in Compliance with the Principles of GLP,
2007.

(16) Doc No. 16, Advisory document of the Working Group on GLP: Guidance on
the GLP Requirements for Peer Review of Histopathology, 2014.

(17) Doc No. 17, Advisory document of the Working Group on GLP: Application of
GLP Principles to Computerised Systems, 2016.

(18) Doc No. 18, OECD Position Paper Regarding the Relationship between the
OECD Principles of GLP and ISO/IEC 17025, 2016.

(19) Doc No. 19, Advisory document of the Working Group on GLP: Management,
Characterisation and Use of Test Items, 2018.

(20) Doc No. 20, Guidance document for Receiving Authorities on the Review of
the GLP Status of Non-Clinical Safety Studies, 2019.

(21) Doc. No. 21, OECD Position Paper Regarding Possible Influence of Sponsors
on Conclusions of GLP Studies, 2020

(22) Rules of Procedure for The Malaysian Standards and Accreditation Council
(RoP-MSAC), 2020

(23) Rules of Procedure for National Accreditation Committee (RoP-NAC), 2020

(24) Rules of Procedure for Appeals Panel (RoP-AP), 2013

(25) CAB 1 – Confidentiality, 2020

(26) CAB 2 – Complaints, 2018

(27) CAB 3 – Appeals, 2020

(28) Accreditation Policy 1 (AP1) - Policy on the Use of Accreditation Symbol and
Reference to Accreditation, 2020

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13.0 LIST OF APPENDIXES

[1] Appendix 1: Standards Malaysia & Accreditation Division Organisation

Chart
[2] Appendix 2: GLP Unit Organisation Structure
[3] Appendix 3: Inspection Process
[4] Appendix 4: GLP-R005: Code of Ethics for Inspectors
[5] Appendix 5: GLP-R004: Undertaking of Confidentiality
[6] Appendix 6: GLP-P016: List of Evidence Document
[7] Appendix 7: GLP-R008: Evaluation Report of Inspector
[8] Appendix 8: GLP-R001: Master Register of GLP Compliance
Programme
[9] Appendix 9: GLP-P001: Application form
[10] Appendix 10: GLP-P004: Notification of Pre-Inspection
[11] Appendix 11: GLP-P005: Pre-Inspection Report
[12] Appendix 12: GLP-P008: Notification of Inspection/ Surveillance
Inspection/ Extra Ordinary Inspection
[13] Appendix 13: GLP-P015: GLP Inspection Checklist
[14] Appendix 14: GLP-P009: Test Facility Inspection Report
[15] Appendix 15: GLP-P012: Certificate of Compliance to OECD GLP
[16] Appendix 16: GLP-P010: Letter of GLP Statement of Compliance

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14.0 LIST OF FORMS

Document GLP-PXXX (P series):

1) GLP-P001: Application form

2) GLP-P002: Dossier for Undertaking Test Facility
3) GLP-P003: Letter of Participation in National GLP CP
4) GLP-P004: Notification of Pre-Inspection
5) GLP-P005: GLP Pre-Inspection Report
6) GLP-P006: Letter of Confirmation of GLP Activities
7) GLP-P008: Notification of Inspection/ Surveillance Inspection/ Extra
Ordinary Inspection
8) GLP-P009: Test Facility Inspection Report
9) GLP-P010: Letter of GLP Statement of Compliance
10) GLP-P011: Memo for Approval
11) GLP-P012: Certificate of Compliance to OECD GLP
12) GLP-P013: Inspector’s Note
13) GLP-P014: Attendance List
14) GLP-P015: GLP Inspection Checklist
15) GLP-P016: List of Evidence Document
16) GLP-P017: Inspector Honorarium (Obsolete)
17) GLP-P018: Letter of Removal

Document GLP-RXXX (R Series):

1) GLP-R001: Master Register GLP Compliance Programme

2) GLP-R003: Annual Overview of Test Facilities Inspected (Obsolete)
3) GLP-R004: Undertaking of Confidentiality
4) GLP-R005: Code of Ethics for Inspectors
5) GLP-R006: Inspector Registration Form
6) GLP-R007: Certificate of GLP Inspector
7) GLP-R008: Evaluation of Inspector
8) GLP-R009: Master List of Manual and Forms
9) GLP-R010: Checklist of GLP Inspector
10) GLP-R011: Appointment letter as GLP Inspector

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15.0 ACRONYM

CAB – Conformity Assessment Body

CMA – Compliance Monitoring Authority
GLP – Good Laboratory Practice
GLP CP – Good Laboratory Practice Compliance Programme
ic – In Compliance
MoH – Ministry of Health
NAC – National Accreditation Committee
NPRA – National Pharmaceutical Regulatory Agency
nic – Not In Compliance
OECD – Organisation for Economic Co-operation and Development

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