Do not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that poor oversight of manufacturing and testing subcontractors will be a concern for the FDA. This concern translates into approval [...]
Archive for the 'Outsourcing' Category
Test Specifications for Stability Studies
Published September 1st, 2009 in 505(b)(2) Process, CMC Issues, How to: and Outsourcing. 0 CommentsPivotal stability programs that are used to generate stability data for NDA submissions are different than research stability programs used to design the drug product, explore packaging configurations, etc. This is common sense, but we have seen instances of pivotal stability programs that have been performed for clients with no defined specifications. A stability protocol [...]
Camargo’s clients are financially backed by the usual funding sources - family & friends, angels, equity investors, etc. Equity sources tend to invest in later stages of development and these funds have been harder to access in this economic climate. As a result, more financial deals are being funded by angels.
Angels are groups of high [...]
Why does Camargo recommend not to use a CMO’s testing lab for development? CMO labs are tailored for commercial production, characterized by many SOP’s and schedules. During early drug development we need answers quickly, sometimes even approximate answers. We’re not bound at this stage by GMPs. We have several outside labs, so we can select one that is [...]
What is a ‘483?
Published December 23rd, 2008 in News Commentary, Outsourcing and Uncategorized. 0 CommentsYou may read in the news or a company press release that a manufacturing site has received a ‘483. This is usually considered bad news. Indeed, failure to remedy observations in a ‘483 can lead to withheld product approvals or even plant closure.
When the FDA makes a visit to inspect a facility (manufacturer, lab, supplier, [...]