Maintaining Good Manufacturing Practices (GMP) is essential for cosmetic companies that want to ensure product quality, safety, and regulatory compliance in the U.S. While the FDA does not require cosmetics to undergo pre-market approval (except for color additives), manufacturers must follow industry-recognized GMP standards to prevent contamination, mislabeling, and product defects.

Under the Modernization of Cosmetics Regulation Act (MoCRA) 2022, FDA oversight of cosmetic safety and manufacturing practices has expanded significantly. Facilities that manufacture, pack, or store cosmetics for the U.S. market are now expected to align with 21 CFR Part 210/211 GMP principles (traditionally applied to drugs) where relevant. This includes robust quality management systems, documented procedures, and strict hygiene controls across production environments.

Key components of cosmetic GMP compliance include:

• Quality Management Systems – Establishing documented policies, SOPs, and continuous improvement programs.
• Personnel & Hygiene Practices – Training employees in sanitation, contamination prevention, and safe handling of ingredients.
• Production & Process Controls – Implementing validated processes to ensure consistent quality across all batches.
• Facility & Equipment Standards – Maintaining clean, controlled environments and properly calibrated equipment.
• Documentation & Recordkeeping – Preserving manufacturing data to demonstrate compliance during FDA inspections.
• Corrective & Preventive Actions (CAPA) – Addressing deviations promptly and preventing future occurrences.

At XPRO America, we help cosmetic manufacturers and global exporters meet U.S. GMP expectations through tailored consulting and compliance support. Our services include facility audits, SOP development, employee training, and audit readiness programs. By adopting strong GMP practices, companies reduce the risk of recalls, consumer complaints, and FDA enforcement actions while enhancing brand credibility in a competitive marketplace.

With consumer safety at the forefront and regulatory requirements evolving under MoCRA, proactive GMP compliance is no longer optional—it is a business necessity. XPRO America ensures your operations meet FDA standards, enabling smooth U.S. market access and long-term growth.

XPRO America provides FDA Cosmetics GMP compliance support, including quality systems, hygiene, production controls, and audit readiness for U.S. market access.