Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
Sterility testing and assurance are critical regulatory compliance requirements for 503B facilities that perform sterile compounding according to USP <797>. Subject to section 503B under the Federal Food, Drug, and Cosmetic (FD&C) Act, 503B facilities...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
MoCRA is here, and it’s reshaping the U.S. cosmetics industry. The MoCRA law covers a wide range of cosmetics and personal care products, and introduces new provisions and grants new powers to the FDA for regulating cosmetic products in the United States, including...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
OTC and OTC-drug crossover products require stability testing, per FDA regulations. And, while FDA doesn’t mandate stability testing for cosmetics, it is the manufacturer’s responsibility to ensure product safety prior to marketing the product, and many...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care
Reviewed and Approved by Lisa El-Shall, Senior Director Drugs and Devices, EAS Consulting Group, a Certified Group company. 1-Minute Summary 21 CFR 211 outlines cGMPs for OTC drug laboratory testing, crucial for product safety and compliance. Mandatory tests include...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care, Supplements
Reviewed and Approved by Dean Cirotta, President – EAS Consulting Group & Executive Director of Regulatory Affairs – Certified Group 1-Minute Summary cGMPs require a thorough OOS investigation if your in-house or third-party lab produces an...
Dec 5, 2024 | Blog, Cosmetics, OTC and Personal Care, Supplements
Reviewed and Approved by Dean Cirotta, President, EAS Consulting Group, a Certified Group company 1-Minute Summary Own Label Distributors (OLD) and Private Label Distributors (PLD) are responsible for ensuring cGMP compliance across all production phases, including if...
![How to Perform an Out of Specification Investigation for OTC Drug Products and Dietary Supplements [Step-by-Step]](https://certified-laboratories.com/wp-content/uploads/supplements-under-microscope.jpg)
