Artificial Intelligence (AI) is set to transform Malaysia’s pharmaceutical industry by enhancing regulatory compliance, streamlining processes, and strengthening industry standards to meet global expectations.
According to YBhg. Dr. Azuana Ramli, Director of the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MoH), AI plays a critical role in improving Good x Practice (GxP) compliance, increasing efficiency in regulatory processes, and elevating pharmaceutical standards.
“AI can revolutionise quality assurance, optimise compliance monitoring, and enhance decision-making in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Vigilance Practice (GVP),” she said in her opening remarks at the National GxP Seminar 2024, held on 17–18 December at Royale Chulan Damansara Hotel.
Themed “Assimilating Artificial Intelligence (AI) in GxP Settings,” the seminar gathered 80 participants from the pharmaceutical, herbal, and cosmetic industries, including manufacturers, distributors, importers, wholesalers, warehouse operators, academicians, and regulatory bodies.
Industry experts from NPRA, the Department of Standards Malaysia, and leading pharmaceutical companies—PharmEng Technology, Ain Medicare, Duopharma Biotech, Pharmaniaga LifeScience, and Xepa-Soul Pattinson—shared insights on AI’s impact on compliance, quality control, and regulatory audits.
A key highlight was a forum discussion moderated by Dato’ Muhammad Lukmani Ibrahim, former Deputy Director of Regulatory Pharmacy and Head of the Centre for Compliance and Licensing at NPRA.
The panel explored NPRA’s regulatory experiences, particularly in conducting audits for GMP, GDP, GLP, and BEEC, and examined how AI-driven systems can enhance efficiency while ensuring strict adherence to regulatory frameworks.
Organised by UniKL RCMP, the seminar reinforced the growing significance of AI integration in GxP settings, highlighting Malaysia’s commitment to innovation, compliance, and pharmaceutical excellence.
