Standards Malaysia was appointed by the Government of Malaysia on 13 February 2008 as the Compliance Monitoring Authority (CMA) besides the National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MoH) for monitoring compliance to the Organisation for Economic Co-operation and Development Principles of Good Laboratory Practice (OECD GLP).
As GLP CMA, Standards Malaysia has adopted the OECD Principles of GLP. The structure, policies and procedures under which Standards Malaysia operates are documented to ensure implementation of these policies and procedures are administered in an independent and impartial manner to ensure the smooth operation of all compliance activities. Standards Malaysia quality system has been established, documented, implemented and maintained to give confidence in its ability to operate the compliance process in an effective manner.
Cooperation with other GLP CMA may include carrying out inspections of test facility/study audit on the request of local/international Regulatory Authority (RA) and foreign GLP CMA.
Standards Malaysia is directly responsible for an adequate team of inspectors having the necessary expertise or is ultimately responsible for such a "team". Details are described in the Standards Malaysia Good Laboratory Practice Compliance Program (GLP CP) Manual.
Standards Malaysia should maintain records of test facilities inspected (and their GLP compliance status) and of studies audited for both national and international purposes.
Malaysian Good Laboratory Practice Committee (MyGLPC)
Malaysian Good Laboratory Practice Committee (MyGLPC) has been established to advise Standards Malaysia as GLP CMA.
Standards Malaysia Good Laboratory Practice Compliance Programme (GLP CP)
Standards Malaysia GLP CP is a voluntary program open to test facilities conducting studies for non-clinical health and environmental safety studies. This program 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. All of these requirements are applicable for all studies or areas of expertise within the scope of Standards Malaysia GLP CP.
The Director General of Standards Malaysia is responsible for GLP CP and its Accreditation Division carries out the daily operations.
The process for inspection generally includes the following stages:
Registration / Inspection Process
Standards Malaysia will inspect, register and monitor test facility on regular basis of approximately two year's cycle in accordance with the Master Register of GLP CP. The programme includes Application, Pre-inspection, Inspection, Surveillance Inspection and/or other Extra-Ordinary Inspection, where applicable.
Registration process will begin with application by Test Facility Management by submission of GLP-P001: Participation in GLP Compliance Program to Standards Malaysia.
An inspector will be appointed to conduct the Pre-Inspection to confirm the GLP activities conducted by the test facility.