It’s appropriate I am writing this blog post in December 2014; exactly one year away from the start of new regulation from U.S. Pharmacopeial Convention (USP) that mandates the testing of fifteen trace elements (metals) in pharmaceutical products from 1st December 2015 onwards as per USP & (link to USP site on these regulations).
So, the clock is now ticking towards this date and I’m meeting nutraceutical, pharmaceutical, and biopharmaceutical manufacturers across the globe that are making preparations to meet these new pharmaceutical regulations.
A day may be a long time in politics; however, a year in laboratory set-up and method validation is worryingly short. For laboratories yet to start preparations, they will be faced with a whole series of challenges that will eat time as the deadline looms, such as, evaluating methods, choosing instrumentation, procurement, installation, qualification, training, method development and validation. A lot to do. Thankfully, I’m delighted to say that help is at hand. I am pleased to announce that we have a number of new tools created to cut down the time it takes you to achieve compliance for USP & .
First, we have created specially designed qualification kits, described in Technical Note 43172, Easy and Rapid System Quantification using the iCAP Series Qualification Kit, (downloadable PDF), to set you up and get you on your way, faster. The technical note also examines all sections of the code and how our software solution supports 21 CFR Part II compliant environments. The kits are a single part number and contain everything you need for system qualification including standard solutions and operating procedures for installation and operational qualification (IQ & OQ) of the system. In addition, the kits also contain a special license to unlock a qualification tool within our 21CFR11 compliant mass spectrometry control and data processing software (Thermo Scientific Qtegra Intelligent Scientific Data Solution Software) where all qualification tests and reports are prepared for you.
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Second, to save yet more time, we’ve done the maths for you. We’ve created specialized reporting tools within the software specifically for USP 232, 233 validation. Sure, these are calculations that can be done on a spreadsheet like other vendors. However, we felt it was better to have this functionality ready for you inside the compliant, auditable, environment of the software.
And, last but not least, we have a created a webpage with all of the information you need to get ready for these changes at USP Chapters and for trace elements (link to webpage). Here, you can also find out more about our solutions including our ICP-OES and ICP-MS products that are capable of meeting the demanding sensitivity requirements of the new legislation.
- On-demand webinar, titled, Learn the Tricks of the Trade to Prepare Your Lab for USP Chapters & , (link to short registration page after which the webinar will play on demand). Experts provide an overview of the new USP chapters and discuss how to setup, validate and transfer methods to production.
- A 12-min, on-demand podcast featuring industry expert Rob Thomas on the basics of USP , and (link to webpage featuring the podcast; press the Play button to start the podcast).
If you have any questions on methods, workflows or products do let us know in the comments box below. Our trace elements experts look forward to hearing from you.