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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.
However, many customers also require support for drug applications in other regulatory markets around the world, where DMFs aren’t an option. West meets that need by making Global Submission Support Packages available to our customers.
Global Submission Support Packages provide customers with the technical information they need to file West products and processes. Each package contains information regarding West components and any other processes applied (e.g., wash, sterilization). The content is specifically designed to meet agency expectations for drug applications. If a reviewing Health Authority requires more information, West Regulatory Affairs (RA) can provide the necessary response.
West currently has packages for the following products and processes:
| Standard elastomers | Westar RS Lined Seals |
| Westar® RS | NovaPure® RS/RU |
| WestarRU Steam | Daikyo Crystal Zenith® (CZ) Vials |
| Westar RU Gamma | CZ Cartridge System |
Special Features of Global Submission Support Packages:
They’re in Common Technical Document (CTD) Format
The CTD format is widely-used around the world and is typically accepted in most major regulatory markets. West’s submission support packages can be easily integrated into customers’ applications in this format.
They’re provided as Word Documents
Having the documents in Word gives customers the flexibility to use the information in their regulatory submissions as needed, for both CTD and non-CTD submissions.
They’re backed by West Global RA Support
West’s Regulatory Affairs department will assist customers in providing responses to any Health Authority questions relating to our products or processes. If confidential information is required as part of the response, West will respond directly to the Health Authority.
For more information, contact West today or visit our regulatory support page
In 2014, the West Women Investing and Networking (WIN) initiative was born under the leadership of Karen Flynn, Sr. VP & Chief Commercial Officer, and a group of female employees at the West U.S. headquarters in Exton.
Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as <em>freeze-drying</em>) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.
Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop <strong>Challenges and Patient Impact of Particles in Biologics</strong>, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: <em>Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.</em> <br />
Small is the new big. Growth in specialty treatments that target smaller patient populations means less emphasis on economies of scale and more focus on adaptable and modular manufacturing.
The answer is – it depends. Your Technical Customer Service (TCS) representative can help you decide. Butyl rubber, derived synthetically from petrochemicals, is a copolymer of isobutylene, and to a smaller extent, isoprene. Subsequent halogenation results in a halobutyl rubber – typically bromobutyl or chlorobutyl.
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