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From the Blog
West logo with Diamond

April 07, 2016

Recent Changes to West’s Elastomer Formulation DMF

Steve LoCastro

Director, Regulatory Affairs

West is the

Largest

Contract Manufacturer of Pens & Auto-Injectors

Regulatory Support

The misson of West Regulatory Affairs (RA) is to provide customers with industry leading support for their global regulatory needs. West RA provides a single point of contact to assist with global registration strategies for all West products and processes.

West RA can provide tools to support customers from initial regulatory evaluation of West products through final health authority approval of drug applications—delivering excellent customer service along the way.
Customers looking to transition into a new West product or process need to start with an evaluation of the likely impact of the change to their regulatory files. This is key to building an efficient regulatory submission strategy that will maximize approvability and minimize the time required to achieve approvals.

West RA can provide customers with regulatory assessments to identify potential regulatory risks, suggest mitigation strategies, and provide references to relevant guidances for support. West regulatory assessment documents can provide customers with the tools needed to help build an overall regulatory submission strategy and facilitate the transition.

Regulatory Affairs provides customers with Regulatory Compliance Certificates to verify that West products and processes meet regulatory agency expectations in all major markets.

Examples of compliance certification letters include:

  • Direct/Indirect Food Contact Regulations
  • Materials of Animal Origin (TSE/BSE Risk Evaluation for Raw Materials)
  • Heavy Metals (Toxics in Packaging Legislation)
  • Natural Rubber Latex/Dry Natural Rubber Content
  • Additives of Concern (phthalates, nitrosamines, etc.)
  • Elemental Impurities
  • Conflict Minerals

West maintains an extensive portfolio of Drug Master Files (DMFs), Master Access Files (MAFs), 510ks and Canadian Licenses with both the FDA and Health Canada. Some of our DMFs are acknowledged to be the most heavily accessed DMFs at either agency. Upon request, West can provide Letters of Authorization/Access (LOAs) to customers for inclusion in their drug applications.

Each year, West provides over 1800 LOAs to its DMFs, using a convenient online request form. West RA has worked with both FDA and Health Canada to define industry standards for conversion of packaging and process DMFs to electronic format (eCTD). The entire West DMF portfolio has been converted to eCTD, so that files are compliant with FDA and Health Canada requirements for electronic DMFs.

The DMF portfolio includes the following West products and processes:

  • Contract laboratory test methods
  • Daikyo Crystal Zenith® vials
  • Daikyo Crystal Zenith cartridge systems
  • Daikyo Crystal Zenith syringe system
  • Elastomer formulations, films and coatings
  • NovaPure® components
  • Steam sterilization process
  • Westar® Ready-to-Sterilize (RS) wash process
  • Westar (RS) washed lined seals
  • Westar® Ready-to-Use (RU) steam sterilization
  • Westar RU gamma sterilization
  • SelfDose® Manual-Injector System
  • SmartDose® Platform

Global Submission Support Packages are intended to support customers in countries where Drug Master Files (DMFs) and Master Access Files (MAFs) have not been established. They provide customers with the technical information for West products and processes needed for inclusion in their drug applications.

The content of each package is designed to meet Health Authority expectations for pharmaceutical components and delivery systems in drug applications and they are backed by West RA support for any follow-up questions you may receive from reviewing agencies. West currently has or can provide packages for the following products and processes:
  • Daikyo Crystal Zenith Cartridge System
  • Daikyo Crystal Zenith Syringe System
  • Daikyo Crystal Zenith Vials
  • NovaPure RS/RU
  • Steam Sterilization Process
  • Standard Elastomers
  • Westar RS Lined Seals
  • Westar RS Wash Process
  • Westar RU Gamma Sterilization Process
  • Westar RU Steam Sterilization process
  • SelfDose Manual Injector
  • SmartDose Platform

When a drug application is being reviewed by a health authority (HA), follow-up questions may be posed and could involve a West component. Regulatory Affairs provides customers with high-quality support for any HA questions regarding West products and processes. West provides the necessary information for inclusion in a response document or can provide responses directly to the relevant agency.
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Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.

SmartDose® is a registered trademark of Medimop Medical Projects, Ltd., a subsidiary of West Pharmaceutical Services, Inc.

SelfDose™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

Westar® and NovaPure® are registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.