First, West can work with you, well in advance of any filing deadline, to address E&L issues, and select the most appropriate packaging products – e.g., stoppers comprising the recently launched formulation: 4031/45 Gray. Being new, the most up-to-date information on the formulation is available – further assurance is that no “special case compounds” are added--as these can pose a risk to patients.
Second, once the packaging components are selected, baseline extractable data on the elastomer component can be provided via the West Extractable Data Guide (West EDGe™). For 4031/45 Gray, the West EDGe guide provides extractables data compiled from a variety of methods, techniques, and solvents. Moreover, the West EDGe guide provides a roadmap, drawn from extensive industry experience that can be used to guide risk-based decisions. The West EDGe guide, combined with West’s experience and consultation, can help you make sense of the extractable and leachable evaluation process in a proven step-wise approach.
Finally, using the data in the West EDGeTM guide, West experts can help you develop a leachables testing plan and execute that plan as needed. From ICH Q9: we know that “the evaluation of the risk should be based on scientific knowledge and ultimately link to the protection of the patient.” With a combination of the right packaging components and the right set of data, you can have confidence that there will be fewer surprises for you and your patients.
West has a variety of solutions, including the AccelTRA™ program, which offers market leading delivery times and a single next generation formulation for stoppers that help customers stay competitive and move to market quickly.
West EDGe™ and AccelTRA™ are trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.