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...
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...
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...
Reviewed and Approved by Matilda Baghdasarian, Associate Director, Certified Laboratories In-package stability testing is an essential phase for any cosmetic, OTC, personal care product, or dietary supplement company. We aim to provide our customers with the essential...
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)
