Quality Assurance & Compliance

GMP & ISO Certified OEM Group Manufacturer in Malaysia

OEM Manufacturing Facility & Business Certifications

ORIZI Group operates modern, high-capacity production plants in Malaysia strictly adhering to recognized international and regional standards for safety, quality management, and ethical compliance.

Cosmetic GMP Certification ASEAN NPRA

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
Food GMP Certification SIRIM MS 1514

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

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 SIRIM

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 Codex Alimentarius MS 1480

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

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 UQAS

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 Audit Intertek Sedex Platform

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 MoCRA & FSMA Facility Registrations

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
Dun & Bradstreet DUNS Registered Manufacturer

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)

Product Quality Compliance & Analytical Testing

Beyond plant-level credentials, every product batch OEM-manufactured by ORIZI Group undergoes rigorous physical, chemical, and microbiological testing to ensure global market acceptability.

JAKIM Halal Certification Malaysia

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 Establishment Licence Malaysia Act 737

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 Analytical Batch Testing

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 and Microbial Testing Screening

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 & Patch Testing

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 Stability & Drop Shipment Testing

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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