Good Manufacturing Practice (GMP) inspections in Malaysia are conducted by the National Pharmaceutical Regulatory Agency (NPRA) to ensure that pharmaceuticals, biologics (including cell and gene therapy products), natural products (including traditional medicines), health supplements, and cosmetics are consistently manufactured and controlled to meet quality standards. The GMP Section, under NPRA’s Centre of Compliance and Quality Control, conducts inspections at both domestic and overseas manufacturing sites.

Inspections are primarily conducted on-site, although remote or alternative methods may be employed when necessary. The inspection standards applied depend on the product category, including the PIC/S Guide to Good Manufacturing Practice for Medicinal Products and its Annexes, the Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements, and the Guideline for Cosmetic Good Manufacturing Practice under the Guidelines for Control of Cosmetic Products in Malaysia.

After each inspection, a report is prepared to document the site’s strengths and any deficiencies, in accordance with the relevant chapters of the applicable GMP guidelines and/or Annexes. Deficiencies are classified as Critical, Major, or Other, based on their potential impact on product quality and patient safety. Inspection data are reviewed by NPRA to identify trends and to assist manufacturers in implementing self-inspections and continuous improvement measures.

Updated on 13 March 2026.