Global certifications and compliance

The U.S. Food and Drug Administration (FDA) is the primary federal regulatory authority in the United States responsible for protecting public health through the rigorous supervision of the safety and quality of food, drugs, medical devices, pharmaceuticals, cosmetics, and dietary supplements.

Although the FDA does not issue traditional “certificates” to individuals like some professional bodies, FDA approval is considered the global gold standard for factories, companies, and laboratories seeking to market their products within the U.S. market or in markets that recognize FDA standards.

Target Groups:

1. Institutions (Companies, Factories, Laboratories):

✅ Types of Approvals:

• Factories: Registration and compliance with Current Good Manufacturing Practices (cGMP).
• Products: Submission of a technical dossier including:
  • Product formulation
  • Safety and efficacy results (especially for drugs and supplements)
  • Product labeling and marketing compliant with FDA regulations
• Laboratories: Compliance with FDA standards for laboratory testing and analysis
• Packaging and Transportation: Must comply with health and thermal regulations to maintain product quality.

2. Individuals (Quality and Manufacturing Professionals):

✅ Training certificates available in areas such as:

• cGMP (Current Good Manufacturing Practices) requirements
• Risk management in food and drug production
• FDA Inspection and Compliance
• Hazard Analysis and Critical Control Points (HACCP) aligned with FDA systems

Benefits of Certification:

✅ For Institutions:

• Access to the U.S. market for exporting food or pharmaceutical products
• Increased global trust in company products, especially in markets such as the EU, Middle East, and Asia
• Reduced risk of customs rejections or regulatory penalties
• Easier collaboration with global distributors and companies requiring FDA approval as a contractual condition

✅ For Individuals:

• Qualification to work in food or pharmaceutical manufacturing facilities compliant with U.S. standards
• Enhanced employment opportunities in quality assurance, compliance, and production control
• Career advancement in companies aiming for regulatory compliance and global product export

General Requirements for Accreditation:

• For factories: Formal registration with the FDA via the FURLS system
• Periodic or surprise inspections by FDA inspectors or authorized agents
• Proof of full compliance with all regulations specific to the product type
• Maintenance of accurate and traceable production records at all stages

Important Notes:

• FDA does not issue “approval stickers” on food products; instead, product registration and the absence of recorded violations serve as the basis for compliance.
• For supplements and cosmetics, the burden of proving safety and efficacy lies with the company before entering the market.