Product Classification, QUEST3+ System Basic, ASEAN Guidance Documents, Guideline For The Submission Of Product Samples For Laboratory Testing & Clinical Trials.

Among the pharmacovigilance activities carried out by NPRA are adverse drug reaction (ADR) monitoring and screening of drug safety alerts. These activities allow identification of drug safety issues, which are reviewed in order to implement preventative measures. NPRA also communicates information on drug safety issues to healthcare professionals and the public, in our ongoing effort increase patient safety.

The submission of sample for laboratory testing is as part of the registration process.This guideline consists of the general and specific requirements for the submission of samples to the Centre for Quality Control for laboratory testing. The general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product.

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.

Any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s Licence, Import Licence or Wholesale Licnese. Licencing unit, Centre for Compliance and Licensing (CCL) involves in the activity of issuance of Licence.

A significant part of the quality of a finished product is dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper system of qualification of suppliers is necessary to ensure a constant sourcing of APIs of appropriate quality and to safeguard the public health interests. This will be done through standardized quality assessment and inspection procedures.