IPEC-Americas volunteers recently added a Frequently Asked Questions (FAQs) annex to the 2018 version of the Excipient Master File Guide and re-issued it as a 2019 version. The annex addresses questions related to excipient DMFs (Type IV) that are commonly asked within the excipient manufacturing community. The 15 questions and responses cover a wide range of master file related issues, such as: “Is it mandatory? What information should it contain? When should it be updated, and how?” Visit IPEC-Americas Document Depot to download this useful and free guide.
Tuesday, April 9, 2019