(509c) Considerations in Choosing Between the Use of Process Data and Analytical Data to Monitor and Control Cqa's in Continuous Drug Product Processes

Continuous drug product manufacturing introduces new risks and opportunities in providing assurance of quality.   Many of these involve the ability to measure or predict product quality and reject/accept/adjust the process in real-time.  The primary approach discussed in the literature for this is through the intensive use of on-line and at-line analytical testing (often referred to as PAT).  A clear definition of the objectives and a first-principles approach to addressing them can result in a greater reliance on achieving routine quality though process monitoring and control and the focusing of analytical testing on those areas not being addressed with process data.  An example is provided for the continuous direct compression platform where potency, blend uniformity and content uniformity can all be assured by the use of process data.  This requires the process meet the criteria of being in a state of control and having good to excellent capability and also having acceptable risk of special cause upsets.  When used in conjunction with process data this approach might also change validation requirements for on-line/at-line analytical methodologies to a less demanding level of rigor depending on its intended purpose.