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’s manufacturing facilities have been awarded Halal certification by the Department of Islamic Development Malaysia (JAKIM). This recognition proves that our sourcing, production processes, and quality controls comply with Islamic dietary requirements. Our Halal-certified premises allow us to serve Muslim consumers globally with confidence and integrity.

Bioalpha has achieved ISO 9001 certification for its quality management system, reflecting a strong culture of continuous improvement. This certification recognizes our structured processes, customer-centric focus, risk management, and data-driven decision-making. The ISO 9001 framework also promotes close collaboration with suppliers and partners, ensuring that quality is embedded across our operations.

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.