Reviewed and Approved by Matt Traynor, PhD, Innovation and Validation Director, Certified Laboratories 1-Minute Summary Method validation ensures testing methods are accurate, consistent, and reliable across different conditions, products, and...
Reviewed and Approved by Steven Rogers, Corporate Quality Manager, Certified Group; Lisa El-Shall, Sr. Director of Drug & Device Consulting, EAS Consulting Group; Tim Lombardo, Sr. Director, Food Consulting Services, EAS Consulting Group On Jan. 15, 2025,...
503B sterile compounding pharmacies are ultimately responsible for their products, even when they outsource quality and sterility testing. Here’s how to ensure your testing partner uses adequate laboratory controls so you can remain compliant and produce safe,...
Enlisting an import agent is a basic requirement for importers of FDA-regulated products. Import agents are the frontlines of communication with the FDA, assisting with the submission of required registrations and listings as well as support with questions posed by...
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...
