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Good Laboratory Practice (GLP) Compliance Monitoring Programme

 The Malaysian GLP Monitoring Authority


OECD GLP Documents | Directive | Application Procedures & Application Form | FAQ

NPCB GLP Compliance Programme Manual | GLP Compliant Test Facilities


Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived and reported. The purpose of the Principles of GLP is to promote the development of quality data.

The Principles of GLP should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetics 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 items is to obtain data on their properties and/or their safety with respect to human health and/or the environment. Non-clinical health and environmental safety studies covered by the Principles of GLP include work conducted in laboratory, greenhouses, and in the field.

The National Pharmaceutical Control Bureau (NPCB) and STANDARDS MALAYSIA (www.standardsmalaysia.gov.my) had been designated as the Malaysian Compliance Monitoring Authorities (CMAs) by the Malaysian Government. NPCB is the CMA for the non-clinical safety testing of test items contained in pharmaceutical products, cosmetics products, veterinary drugs and food additives. Whereas STANDARDS MALAYSIA is the CMA for the non-clinical safety testing of test items contained in industrial chemicals, pesticides, feed additives, and biotechnology (non-pharmaceuticals). For NPCB the decision by the Government of Malaysia is enforced by the issuance of A Directive under Regulation 29 of the Control of Drugs and Cosmetics Regulations 1984 in June 2009.

The GLP Compliance Programme (CP) is intended to ascertain whether Test Facilities have implemented requirements as described in documents of Organisation for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring. Test Facilities requesting for verification and certification of compliance to Principles of GLP, and subsequent inclusion into the CMAs GLP Compliance Programme need to make the relevant application to CMAs.

There is a close cooperation between NPCB and the STANDARDS MALAYSIA. Joint inspections of Test Facility will be carried out together at the request of Test Facilities. If a Test Facility conducts studies that fall under the scope of NPCB and also studies which fall under the scope of STANDARDS MALAYSIA, a Test Facility may request a joint inspection by both CMAs by putting a parallel application to both CMAs for GLP Certification. In other occasions, NPCB may also invite inspectors from STANDARDS MALAYSIA to participate in their inspections from time to time and vice versa.

The GLP Compliance Program includes Pre-Inspections, Inspections, Surveillance and Extra Ordinary Inspections. Pre-inspection is carried out for the first time to familiarize and verify that the Test Facility has the resources to undertake GLP studies in respect of management structure, physical layout of buildings and ranges of studies. The Test Facility Inspections shall be a full inspection that involves both Test Facility and Study Audit (completed studies and/or on-going). Surveillance Inspections will be conducted annually for the first two years and subsequent surveillance inspections in every two years at least three months from the date of the compliance certificate expires. Extra Ordinary inspection shall be carried out in situation not covered by Pre-Inspections, Inspections and Surveillance Inspections. Test facilities complying with requirements as described in documents of Organisation for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring shall be listed in the Master Register in the GLP Compliance Programme. The Test Facilities listed in the Master Register shall be monitored periodically.

Effective from 29th March 2013, Malaysia is officially a non-member with full adherent to the Organisation for Economic Cooperation and Development (OECD) Council Acts related to Mutual Acceptance of Data (MAD) in the Assessment of Chemicals on Good Laboratory Practice (GLP). At present, thirty-four (34) OECD countries and six (6) non-member countries i.e. Argentina, Brazil, India, Malaysia, Singapore and South Africa adhere to the system.

The GLP Compliance Programme will help our Test Facilities gain the acceptance of their non-clinical health safety studies into OECD countries and others members who adhere to OECD, thus reducing duplicative testing and shortening time-to market for new products.

It will also provide assurance to both local and overseas regulators that the non-clinical studies from Test Facilities is a true reflection of the results obtained from the studies. With GLP recognition, health and environment non-clinical safety studies done locally will enjoy greater access to international market.

Detailed information and condition regarding procedures under which test facilities inspections and study audits are performed can be found in the NPCB GLP Compliance Programme Manual.


OECD Good Laboratory Practice (GLP) Documents

(below are documents on GLP from the OECD for your quick reference:)

 

Directive on the Appointment of NPCB as the Malaysian Compliance Monitoring Authority (CMA):  [ English | Bahasa Malaysia

Document Name

OOECD Principles on GLP 
Guidance for GLP Monitoring Authorities - Procedures for GLP
Guidance for the conduct Labt. Inspection and Study Audit
Quality Assurance and GLP
Compliance of Laboratory Suppliers with GLP Principles
The Application of the GLP Principles to Field Studies
The Application of the GLP Principles to Short Term Studies
The Role and Responsibilities of the study Director in GLP Studies
Guidance for the Preparation of GLP Inspection Report
The Application of the Principles of GLP to Computerised System
The Role and Responsibility of the sponsor
Requesting & Carrying Out Inspections & Study Audits in Another Country
The Application of the OECD Principles of GLP to the Organization and Management of GLP
The Application of the OECD Principles of GLP to in-vitro studies 2004
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
Guidance on the GLP Requirements for Peer Review of Histopathology
Application of GLP Principles to Computerised Systems
OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025

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