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PROGRAMME MANUAL  \nNATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA)  \nMINISTRY OF HEALTH MALAYSIA  \nVERSION 4 (2022)  \nLot 36, Jalan Profesor Diraja Ungku Aziz (Jalan Universiti), Petaling Jaya, Selangor Darul Ehsan, Malaysia  \nTel: 603-7883 5400 [Website:](Website: www.npra.gov.my)[ ](Website: www.npra.gov.my)[www.npra.gov.my](Website: www.npra.gov.my)  \nACKNOWLEGEMENTS  \nAdvisor:  \nDr. Noraida Mohamad Zainoor Head of Centre for Compliance and Quality Control National Pharmaceutical Regulatory Agency (NPRA)  \nEditor-in-Chief, GCP and GLP Section, Centre for Compliance and Quality Control, National Pharmaceutical Regulatory Agency (NPRA):  \nAzura Abdullah  \nPoh Wen Tsin  \nFadhilah Hasbullah  \nFauziah Mohamed Kasim  \n1.0 INTRODUCTION  \nThe manual describes the quality system of the National Pharmaceutical Regulatory Agency (NPRA) as 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 documents.  \nMinistry of Health Malaysia is the coordinator for Good Laboratory Practice (GLP) Compliance Monitoring Programme (CMP) in Malaysia. Two Compliance Monitoring Authorities (CMAs) were appointed by the Malaysian Government. The two appointed CMAs are National Pharmaceutical Regulatory Agency (NPRA) , Ministry of Health Malaysia and Department of Standards Malaysia (STANDARDS MALAYSIA), Ministry of International Trade and Industry (MITI) , Malaysia.  \n2.0 OBJECTIVE  \nThe objectives of this manual are to provide:  \n􀁸 Policies and procedures of NPRA as the national CMA in operation of national Good Laboratory Practice Compliance Programme  \n􀁸 Mechanism for listing of test facilities into the GLP Compliance Programme  \n􀁸 Process on conduct of inspection on test facilities and study audit.  \n􀁸 Reporting of the inspection and study audit.  \n􀁸 To exchange information with other national CMA according to provision of OECD.  \n3.0 SCOPE  \nGLP Compliance Programme is a voluntary programme open to test facilities conducting nonclinical health and environmental safety studies and for purpose of registering and/or licensing on test item contain in product in the following categories:  \n􀁸 Pharmaceutical products  \n􀁸 Cosmetics products  \n􀁸 Veterinary drugs  \n􀁸 Food additives  \n􀁸 Medical Devices  \nFor chemicals such as pesticides, feed additives, industrial chemicals and non-pharmaceutical biotechnology products will be inspected by the Department of Standards Malaysia (Standards Malaysia), Ministry of International Trade and Industry (MITI), Malaysia ([http://www.jsm.gov.my/](http://www.jsm.gov.my/)) which is the other CMA. There is a close cooperation between both CMAs. Mutual cooperation is signed by both CMAs.  \nAppendix 1: Mutual Cooperation  \nThese 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 and in the field.  \nType of studies/area of expertise on test item subjected to GLP Compliance Programme:  \n􀁸 Physical-chemical testing  \n􀁸 Toxicity studies  \n􀁸 Mutagenicity studies  \n􀁸 Analytical and clinical chemistry testing  \n􀁸 Other studies (test facility to specify)  \n4.0 TERMS AND DEFINITIONS  \nThe 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.  \nThe following documents were referred in preparation of this manual:  \n􀁸 Doc No. 1 :","cbCaifDcf9YlLUhE","https://ap.wps.com/l/cbCaifDcf9YlLUhE","pdf",2063691,23,"English","# Introduction\n# Objective\n# Scope\n# Terms and Definitions\n## Appendix 1: Mutual Cooperation","[{\"question\":\"What is the purpose of the NPRA GLP Compliance Programme manual?\",\"answer\":\"It defines NPRA’s quality system and compliance monitoring role as a national CMA for overseeing adherence to OECD Principles of Good Laboratory Practice (GLP), supplemented by related documents.\"},{\"question\":\"What does the manual cover under its objectives?\",\"answer\":\"It provides NPRA policies and procedures, the mechanism for listing test facilities, the inspection and study audit processes, reporting requirements, and information exchange with other national CMAs under OECD provisions.\"},{\"question\":\"Which test facility and product categories fall within the programme scope?\",\"answer\":\"The programme is voluntary for test facilities conducting nonclinical health and environmental safety studies for registering and/or licensing products including pharmaceutical products, cosmetics, veterinary drugs, food additives, and medical devices.\"}]","GOOD LABORATORY PRACTICE (GLP) COMPLIANCE PROGRAMME MANUAL - Version 4 - 2022 objectives | PDF",1790955598,58]