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Because differences exist between regulatory agencies from region to region, West regulatory affairs continually stays informed of new developments and changes in order to provide customers with accurate regulatory support regarding packaging requirements.
With a keen understanding of various regulatory agencies’ positions specific to our products, West’s regulatory affairs team offers unparalleled global submission support. In particular, West specializes in Common Technical Document (CTD) sections 3.2.P.7 for container closure systems, as well as 3.2.P.3.5 for process validation and 3.2.P.3.3 for process description related to wash and sterilization processes.
In the United States and Canada, West offers Drug Master Files (DMFs) for:
West also provides a Letter of Authorization/Access to DMFs and responds to agency requests either confidentially or non-confidentially, where the response goes directly to the customer.
Knowing regional differences not only helps to navigate the regulatory process, but ultimately strengthens the composition of submission dossiers. West customers can trust that our regulatory team has the knowledge and the experience to deliver a complete submission within the respective region or country.
Please check back for upcoming blogs to learn more about West’s specialized experience with food compliance, animal derived substances and natural rubber/latex.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
West’s customers are very familiar with our Drug Master Files (DMFs) and Letters of Authorization. West maintains some of the most active DMFs held by the FDA and Health Canada, and we’ve provided customers with over 9,000 LOAs since 2008.
<p style="margin: 0in 0in 10pt;"><span>In <a href="/blog/2017/may/part-1-packaging-supplier-reg-sup-for-med-products">Part 1</a> of this series, we discussed the primary questions to consider when evaluating potential regulatory support from a packaging component supplier. Beginning with this post, we’ll start to look into each of these questions in more detail.</span></p>
For many years, West has offered several ready-to-sterilize products that are qualified for a minimum 3-log Bacterial Endotoxin Reduction (BER). “Ready-to-sterilize” is known to West customers in Europe as “RS” quality. In other regions, such as South America or Asia, the ready-to-sterilize line of products includes our Superior Clean Product® (SCP) components and Enhanced Performance Products (EPP). These offerings reflect West’s commitment to quality components that support pharmaceuticals and biopharmaceuticals throughout the product lifecycle, while also fulfilling various regional market needs.
While all major regulatory agencies have expectations regarding the ability of a pharmaceutical wash process to provide a suitable level of pre-sterilization depyrogenation, the United States (U.S.) Food and Drug Administration’s (FDA) requirements appear to be particularly stringent.
<p>Both the FDA and Health Canada have issued guidances to industry that require Drug Master Files (DMFs) to be provided in electronic formats by defined deadlines.</p>
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