Accreditation

Good Laboratory Practice Compliance Program (GLP CP)

 

INTRODUCTION

GLP Compliance Monitoring Authority (CMA) 

Standards Malaysia is one of the CMAs appointed by Cabinet of Malaysia on 13 February 2008 as the Compliance Monitoring Authority (CMA) for monitoring compliance with 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 RA 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 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.

INSPECTION PROCESS

 

The process for inspection generally includes the following stages:

 

 

 

Standards Malaysia will inspect, register and monitor test facility on regular basis in accordance with the Master Register of GLP CP. The program includes request, Pre-inspection, inspection, surveillance inspection and/or other verification inspection (where applicable). 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.

 

REGISTRATION PROCESS

Registration process will begin on the request of 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.