Connecting the dots within your Quality Management System
In Big Pharma and the life sciences industry, product development is a massive effort that spans several different functions and documents. This process is not only costly, but involves long timelines and requires a breadth of resources to accomplish. Both categories are often being kept in different locations, forcing overall process to depend mainly on tribal knowledge. Despite having a great Quality Management System (QMS), many companies lack a coherent index of the complete process. They lack a good set of Detailed Product and Process Descriptions (DPPDs).
Detailed Product and Process Description (DPPD) is a single document that is used to provide evidence of the systems and processes in place, but can also be used for development and commercialization under Current Good Manufacture Process (CGMP). By including all Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and a listing of all related development documentation, a DPPD can easily illustrate traceability from the conception of the process to the commercial launch of the product.
A DPPD serves to illustrate manufacturing process control to the FDA, and/or any other agency that would require adherence to 21 CFR Part 820. DPPDs save time and money when it comes to tracking information down on a given product, using the deliverables as a source of savings when it comes to new product development. DPPD’s can lower Research and Development costs and timelines to commercialization by having all the information in one location, and having all parties align with the vision of the process at its inception.
If you could see your team and company benefit from adding Detailed Product and Process Descriptions to your existing or future products, don’t hesitate to reach out to Kymanox for a quick, no obligation discussion.
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