Chief Scientific Officer, Strategy & Science Integration
May 01, 2020
Creating a holistic, well rounded approach that puts management of risks at the center of development will be critical to address key CP issues, including:
- Developing a strategic plan for CP development, study designs, and regulatory approval
- Merging aspects of design controls with Quality by Design (QbD) concepts
- Acquiring appropriate data to meet evolving global expectations
- Utilizing the total product lifecycle model (TPLM) with feedback loops at CP inception
- Building line of sight data packages to support development through regulatory approval
- Generating a deep understanding of product and process to minimize development and post approval changes
- Creating a two-way communication channel with transparency throughout the supply chain
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Awareness of the ever-changing technical and regulatory landscapes in the pharmaceutical industry is an essential element of West’s focus on the safe and efficient delivery of drug products. For more on how West can support CP development, contact an Account Manager or Technical Customer Service (TCS) representative.