As technologies become available that allow us to better monitor and understand manufacturing processes, quality professionals will be able to make decisions more quickly, so lead times will shorten. As analytical testing moves from the traditional quality control (QC) laboratory to the production floor, one of the challenges is how to ensure the required independence of QC from production.
However, current good manufacturing practice (GMP) guidelines contain limited specific guidance on how a real-time release testing (RTRT) process can be achieved – this lack of supporting guidelines represents a risk that the adoption of RTRT will be slow or slowed.
Industry needs to understand the key areas where RTRT will impact the pharmaceutical quality system (PQS) and some potential solutions to ensure the objectives of the PQS and patient safety can be maintained.
This is why BioPhorum has published How to keep quality control (QC) independent from production in the move to real-time testing.
Our paper addresses the compliance challenges of RTRT and continued compliance with current GMP standards. To evaluate these challenges, we cover subjects such as QC independence from production, ownership of analytical equipment and results, handling deviations, and the structure of a PQS. We also discuss the GMP requirements applicable to each. It talks about the impact of RTRT on your QC team and how it will allow faster and more consistent implementation of these processes.
The batch disposition process currently starts at the end of the production batch and requires long-lead-time analytical tests with human oversight and review. This process neglects the wealth of data available from modern manufacturing equipment that can perform real-time tracking and predict process performance. We think applying our paper’s principles to real-time processes will help us all realize the benefits.
Is the PQS suitable for defining the standards and operating guidelines for an RTRT process?
We think the answer is ‘Yes’ as the overarching quality principles are the same – but the detailed elements that your quality professionals will need to be responsible for will differ in many cases. Our paper not only outlines some of these differences but gives you some potential solutions.
Deborah Hill
Global Change Facilitator, In-Line Monitoring and Real-Time Release workstream, BioPhorum Fill Finish
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