Bioalpha has obtained Good Manufacturing Practice (GMP) certifications for Functional Food as well as Traditional Medicines & Health Supplements (TMHS). The Functional Food certification, overseen by the Ministry of Health (MOH), requires stringent hygiene standards, safety controls, clear SOPs, staff training, and full production traceability. The TMHS certification, regulated by the National Pharmaceutical Regulatory Agency (NPRA), demands even higher standards including raw material verification, batch documentation, and comprehensive quality-control testing. These achievements reinforce our commitment to producing safe, high-quality products that meet both local and international requirements.

Bioalpha is HACCP-certified, demonstrating our robust food safety management system aligned with Ministry of Health Malaysia (MOH) guidelines. Key steps include hazard identification, critical control point monitoring, staff training, and detailed documentation. Regular internal audits and an external audit from a third-party certification body ensure continuous compliance. This certification underscores our ability to maintain the highest safety standards throughout the supply chain.

Bioalpha has obtained MeSTI (Makanan Selamat Tanggungjawab Industri) certification as part of its commitment to food safety and regulatory compliance. MeSTI, introduced by the Ministry of Health Malaysia (MOH), focuses on the implementation of basic food hygiene and safety practices across manufacturing processes. To achieve this certification, Bioalpha established a structured food safety assurance system covering areas such as cleanliness, operational controls, traceability, and record-keeping. This achievement reinforces the company’s dedication to safe and hygienic production practices, particularly for functional food and beverage categories.

Bioalpha has successfully obtained HALAL certification from the Department of Islamic Development Malaysia (JAKIM), demonstrating its commitment to producing products that are compliant with Islamic principles. The certification process involved a thorough review of all ingredients, manufacturing processes, equipment, hygiene practices, and storage conditions to ensure they meet HALAL standards. Bioalpha strictly handles only HALAL-compliant ingredients, with no use of non-halal substances, guaranteeing that all materials, processes, equipment, and storage conditions adhere to Islamic requirements.

Bioalpha is registered with the United States Food and Drug Administration (USFDA) as a certified food-processing facility in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This registration authorises us to manufacture, process, pack, and export food and dietary supplement products to the United States while maintaining strict hygiene, facility controls, traceability, and GMP/HACCP standards.

Bioalpha successfully completed product registration, environmental monitoring, and testing with CAIQTEST Malaysia Sdn Bhd—the only authorized service center in Malaysia representing the Chinese Academy of Inspection and Quarantine (CAIQ). We were awarded the “Quality and Safety Plant” recognition, confirming our readiness for export to China. This collaboration strengthens Bioalpha’s compliance with Chinese import regulations in food and health products, providing assurance to regulators and consumers about the safety, quality, and traceability of our offerings.