on 26 June 2024 | By Kevin Rowland, Executive Vice President & General Manager of Jordi Labs, an RQM+ Company
Analytical testing is a cornerstone of pharmaceutical development. It is, of course, essential for ensuring the efficacy and safety of drugs released to market. But compliance and process optimization needs go hand-in-hand with product QA/QC. Various test methodologies factor...
Read Moreon 30 January 2013 | By Ryan Kasun
Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four...
Read Moreon 10 December 2012 | By Ryan Kasun
In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
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