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Save the dates for West’s 2012 Educational Series. Join us as our subject matter experts present “Pharmaceutical Development Considerations: Injectable Delivery Systems Quality Planning.”
This free, full-day, educational seminar for pharmaceutical professionals provides an overview of container closure and delivery systems for injectable dosage forms along with critical factors for selecting the appropriate system for applications from development through commercialization.
You’ll hear from technical experts on topics such as:
Mark your calendars now for the following events:
Watch for registration information here on the West Blog. We’ll see you there!
Small things sometimes come in large packages. When it comes to pharmaceutical components, small items like stoppers and plungers are often sold in quantities large enough to supply drug products to the world. But sometimes, and in particular during the early stages of drug development, large quantities are just too much of a good thing.
The regulatory environment is moving to a more science-based approach to Container Closure Integrity (CCI). This is driven by the recent publication of United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Recently, West gave a webinar (377 registrants) titled <a href="https://www.youtube.com/watch?v=5K8R1jumXyU&feature=youtu.be">Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution</a>, that addressed Chapter <1207> and other topics. The survey questions (over 100 responses) from this webinar are instructive.
<span>There’s nothing like a good old-fashioned bake sale to raise money for your favorite cause. </span>
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to adhesives used in their manufacture and to tungsten oxides generated during needle placement.
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