(111b) Incorporating “Process Efficiency” Attributes and Lean Thinking During API Product Development”

Risk assessments are routinely used within Pfizer during product development to help teams identify areas of concern, prioritize experimentation and collate process understanding. In addition to focusing on QbD-type attributes, there is value in understanding process efficiency-type attributes (e.g. for API - filterability, phase separation, ease of cleaning, etc) and identifying those parameters and attributes which may have an impact. Examples will be presented which demonstrate the value of such an exercise. Lean manufacturing is concerned with reducing lead time, inventory and non value added work across a product value stream. Applying ?lean? principles during product development (e.g. telescoping steps, employing PAT) has many benefits, examples of which will also be presented.