A Quality Management System is your best defense on the regulatory battleground, whether you’re selling in the U.S., abroad or both.
Liquid Bones offers the only QMS (Quality Management System) that was developed specifically for e-liquid manufacturers that must comply with both U.S. FDA and EU TPD regulations..
We also offer the training you need to implement the ISO 9001:2015, the gold standard in manufacturing and everything you need to be ready for certification.
The FDA’s deeming regulation, effective on Aug. 8, 2016, requires all e-liquid manufacturers to prepare a PMTA (Premarket Tobacco Application) for the agency’s intense scrutiny.
Each PMTA must include (quoting the FDA) “copies of SOPs to enable FDA to more fully understand the methods used in, and the facilities and controls used for, the manufacturing and processing of the new tobacco product.”
While the TPD is not as specific as the FDA, the European Commission still expects manufacturers to be capable of producing consistent lots of products and follow quality standards.
This comprehensive and customized documentation set includes all of the documents needed to comply with the U.S. FDA and the EU TPD and eventually become ISO 9001 compliant.