CURRENT REGULATORY REQUIREMENTS FOR STERILE PRODUCTS
August 13, 2019
USA (United States of America)
The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised in 2012.