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Manufacturers of parental drug package/delivery systems must be up-to-date on the ever-changing regulatory landscape. At Pharmapack 2017, Fran DeGrazio, Vice-President of Scientific Affairs and Technical Services, spoke on the topic of metal impurities in a presentation entitled: The Changing Regulatory Environment Concerning Elemental Impurities and Container Closure Systems
Reviewed in the presentation are three new guidances and how they relate to package/delivery systems:
ICH Q3D applies to new drug products in NA, EU and Japan - considering 24 metals that must be controlled as potential sources of toxicity. A risk-based approach to understanding and controlling these impurities is presented – with emphasis on permissible exposure levels and potential sources (e.g., raw materials, excipients, manufacturing equipment and package/delivery systems). USP Chapters <232> and <233> will replace <231> (Heavy Metals) as of 1-Jan-2018. In line with ICH Q3D, Chapters <232> and <233> discuss not only permissible exposure levels of 24 metals, but analytical methods for detecting and measuring them. Combined, these guidances provide a comprehensive strategy to understand, control, and measure metal impurities in finished drug products. It is imperative for a manufacturer of package delivery/systems to know the regulatory landscape and how regulations interact. West has this knowledge and can couple it with extensive analytical capabilities to support customers in their development efforts.
To download this presentation and for additional scientific insights on key areas of expertise visit The West Knowledge Center.
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.
The revision to the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals standard becomes official on December 1, 2013. The revision will limit printing to <span style="text-decoration: underline;">only</span> cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product sold within the United States. Seals with the embossed “Flip-Off” or printed with other non-cautionary labeling will not be compliant with this new standard.
<p>Tibor Hlobik, Director, Prefillable Solutions and Technologies<br />Mike Gills, Customer Technical Support Process Engineer</p><p>Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This <span style="text-decoration: underline; color: #0000ff;"><a href="https://www.westpharma.com/west-login">poster</a></span> will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.</p>
<p>We are proud to announce our inaugural Corporate Responsibility Report. West’s commitment to sustainability and remaining active in the areas where we live and work are integral to West’s culture. In Parts 1-3 of this five-part blog series on the report, we focused on West’s efforts in <a href="/blog/2017/june/corporate-responsibility-for-2016">Compliance and Ethics</a>, <a href="/blog/2017/july/corporate-responsibility-report-part-2-philanthropy">Philanthropy</a> and <a href="/blog/2017/july/corporate-responsibility-report-part-3-celebrating-diversity">Diversity</a>.</p><p>The fourth part of the five-part series on West’s Corporate Responsibility discusses West’s Health and Safety programs.</p>
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