Quality Assurance & Compliance
GMP & ISO Certified OEM Group Manufacturer in Malaysia
Good Manufacturing Practice (GMP) – Cosmetics
Certified under ASEAN Cosmetic Guidelines by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Ensures stringent control over personnel hygiene, cleanroom air quality, process validation, and batch traceability.
Held by Dr Orizi (M) Sdn. Bhd. | NPRA Registered
Good Manufacturing Practice (GMP) – Food & Supplements
Certified against MS 1514 standard by SIRIM QAS International and the Ministry of Health Malaysia. Verifies preventive sanitation, raw material auditing, and controlled processing for functional foods, RTD drinks, and dietary supplements.
Held by D&O Nutraceutical & Nutrizens Wellness
ISO 22716: Cosmetic cGMP Standard
The globally recognized International Standard for Cosmetic Good Manufacturing Practices. Benchmarked for export into the European Union, United States, and Asia-Pacific markets to guarantee product stability and safety.
Held by Dr Orizi (M) Sdn. Bhd.
ISO 22000: Food Safety Management System
Comprehensive ISO benchmark integrating HACCP principles with organizational food safety management. Provides audited, end-to-end assurance from raw material handling to export shipping.
Held by D&O Nutraceutical (SIRIM FSMS 00229) & Nutrizens
HACCP Certification (Hazard Analysis Critical Control Point)
Preventive food safety framework certified to MS 1480 by SIRIM QAS and Ministry of Health. Identifies biological, chemical, and physical hazards across manufacturing stages to protect consumer health.
Held by D&O Nutraceutical (HACCP 00425) & Nutrizens
ISO 13485: Medical Device Quality Management System
Specific international quality system standard for medical gel formulations and healthcare devices. Assessed by KGS Certification to mandate strict risk management, sterile barrier controls, and regulatory compliance.
Held by Imedify Medical Solution & Skyler Medical
SA8000: Social Accountability Certification
Premised on International Labour Organization conventions. Independently audited by UQAS to guarantee safe workplaces, fair wages, zero child labor, and responsible labor treatment across production lines.
Held by Dr Orizi (M) Sdn. Bhd. (Cert: IAS/MYS/10152)
SMETA Audited (Sedex Members Ethical Trade Audit)
Audited by Intertek under the 4-Pillar SMETA framework covering Labour, Health & Safety, Environmental Management, and Business Ethics. Transparency data is directly accessible via the global Sedex platform.
Held by Dr Orizi (M) Sdn. Bhd. (Sedex ZS: ZS416762168)
US FDA Establishment Registrations (MoCRA & FSMA)
Registered foreign facility under US FDA MoCRA for cosmetic exports (FEI: 3041511808) and US FDA FSMA for food and supplement exports (Reg: 14791969014), enabling seamless entry into North American retail channels.
US FDA Registered Exporter Facilities
D-U-N-S® International Business Identification
Global nine-digit identification issued by Dun & Bradstreet to verify legal entity status, corporate standing, and operational legitimacy for international buyer due diligence.
D-U-N-S: 66-058-7789 (Dr Orizi) & 47-325-1431 (D&O)
JAKIM Halal Certification
Issued by the Department of Islamic Development Malaysia (JAKIM) under MS 2634 (Cosmetics) and MS 1500 (Food). Fully recognized across ASEAN and GCC regions for authentic Halal-compliant branding.
JAKIM Halal Hub Registered
MDA Medical Device Establishment License
Licensed by the Medical Device Authority (MDA) under Act 737 in Malaysia. Authorizes legal manufacturing, clinical testing, and registration for ultrasound gels, conductive gels, and wound care devices.
Licence MDA-7882-K125 & MDA-7783-K125
Certificate of Analysis (COA) & MSDS
Complete laboratory documentation accompanying every batch. Validates chemical specs, active levels, pH balance, and material safety compliance (MSDS) needed for international freight clearance.
Standard Batch Delivery Document
Heavy Metal & Microbial Screening
Independent analytical testing confirming absence of harmful contaminants including Lead, Arsenic, Mercury, Cadmium, and pathogenic microorganisms (E. coli, S. aureus, Pseudomonas).
Accredited Lab Validation
Clinical Dermatological & Efficacy Testing
In-vivo patch testing, hypoallergenic evaluation, and clinical efficacy trials for aesthetic skincare, sensitive skin solutions, and cosmeceuticals.
Dermatologically Certified Formulations
Packaging Integrity & Transport Testing
Accelerated heat-humidity stability testing, container seal integrity, stack compression, and transit drop testing to protect products against overseas shipping conditions.
Export Freight Approved
Build Your Global Brand with Certified Compliance
Partner with Malaysia's most comprehensive OEM/ODM manufacturing group. Contact our product specialists to request compliance dossiers, sample kits, or custom formulation quotes.
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