Product and Process Knowledge and Development
Part 3 of the Good Supply Practices Series
West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier University. This is the third installment in a four-part series on supply chain management.
At the outset of the Integrity of Supply Initiative, an assumption was that suppliers cannot consistently supply what is needed. However, it was discovered through our research that manufacturers often do not know what specifications are actually needed, do not involve suppliers in development discussions, do not explore the full expertise of suppliers, do not understand their own process well enough to know how the incoming material will impact their process, and do not ask for the process capability of their suppliers.
The contribution to the Good Supply Practices (GSPs) related to this theme will address measures that can be taken to improve product and process development, including:
- Understanding finished process and material requirements
- Standardized stage gate model that can guide development practices
- Exploring the capabilities of suppliers
- True involvement of suppliers in development and improvement opportunities
- Knowledge transfer
A key element of this theme is doing it right to begin with, so involving the right functional groups upfront and understanding how to effectively engage suppliers are critical to the success of product and process development.
It is critical that any GSPs developed out of the Integrity of Supply Initiative be pragmatic (i.e. business smart), provide harmonization where possible, and establish best practices that can be implemented irrespective of company size. To that end, Working Groups have been established and charged with the task of including decision making tools where possible, such as flow charts and matrices, such that the practices can be implemented in a meaningful way. It is important to keep in mind that the GSPs are not to be prescriptive and confining, but rather provide options and best practices to apply appropriately relative to the need and commensurate with the criticality.
My next blog will discuss Driving Ideal Behavior. To learn more about any of those topics, I’d like to invite you to join me at the FDA/Xavier University PharmaLink Conference, March 24-27, 2015. At the conference, you’ll work side-by-side with regulators to deepen the understanding on both sides of the challenges and opportunities the Initiative is seeking to uncover.
I look forward to seeing you there!
Previous Blogs from Dr. Phillips: