In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. Under the Modernization of Cosmetics Regulation Act — MoCRA — the FDA now has explicit authority to establish GMP regulations for cosmetics. Today I’m walking you through what cosmetic GMP means for your manufacturing operation.
Good Manufacturing Practices for cosmetics establish minimum standards for the methods, facilities, and controls used in manufacturing, processing, packing, and holding cosmetic products. The goal is to ensure that cosmetics are safe and properly manufactured.
Key elements of cosmetic GMP include: facility design and maintenance — your facility must be clean, well-maintained, and designed to prevent contamination; equipment — equipment must be appropriate for its intended use, maintained, and cleaned regularly; personnel — employees handling cosmetics must have adequate training and maintain proper hygiene; quality controls — you need written procedures for production, testing, and quality review, and you need to follow them; and record-keeping — you must maintain records that document your compliance with GMP requirements.
Under MoCRA, the FDA is in the process of developing specific cosmetic GMP regulations. Once finalized, these regulations will be legally binding for cosmetic manufacturers. Smaller businesses — those with less than $1 million in annual sales — will have additional time to comply.
Getting ahead of GMP requirements now, before the regulations are finalized, puts you in a much stronger position. We help cosmetic manufacturers assess and build their GMP programs. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.