APQR in Continuous Manufacturing: Rethinking the Annual Cycle

Why We Need to Look at APQR Differently for Continuous Manufacturing 

The Annual Product Quality Review (APQR) is a familiar process for pharma companies. It’s where we pull together data from the past year to check how well our products and processes are performing. It helps prove to ourselves — and to regulators — that everything is under control. 

But things get trickier when you move to continuous manufacturing (CM). In a CM setup, products are made in a steady flow, often around the clock. Unlike traditional batch processes, there aren’t clear breaks or “batches” to group together. This means the usual way we do APQR may not really fit. 

Why Old APQR Methods Don’t Quite Work for CM 

  No neat “yearly batches” to group:
In batch manufacturing, you look at all the batches made in a year. In CM, there are no obvious batches. You might be producing nonstop, with only packaging breaks or raw material changes to mark any division.

  Trends can get lost:
APQRs are meant to spot trends over time. But CM is monitored constantly with tools like PAT (process analytical technology) that can catch issues right away. Looking only at yearly summaries might miss what’s actually happening day-to-day.

  Deviations look different:
In batch processes, you might see a deviation tied to a single batch. In CM, small process shifts happen, get corrected fast, and don’t impact final quality — but you still need to track them properly.

How to Make APQR Work for Continuous Processes 

Pharma companies running continuous lines are handling APQR in smarter ways, such as: 

✅ Doing more frequent reviews:
Instead of waiting for a once-a-year review, they look at data every month or quarter, then pull it all together annually. This means problems are spotted and fixed faster. 

✅ Watching trends differently:
They use data analysis tools that handle lots of continuous data to catch tiny drifts before they become big issues. 

✅ Redefining what a “batch” is:
For paperwork, they might decide that every X kilograms or every time a new raw material lot starts counts as a batch, so they still meet regulatory needs. 

✅ Including more real-time data:
APQRs for CM often include graphs and reports straight from PAT systems, not just final QC results. This shows the process stayed controlled the whole time. 

✅ Recording small fixes:
Instead of hiding quick process adjustments, they document them as proof the system is working as it should. 

APQR Can Be a Big Advantage 

Regulators like the FDA and EMA actually encourage modern manufacturing. They expect that if you’re doing continuous manufacturing, your APQR will reflect that — not just copy old batch approaches. 

Handled well, your APQR for continuous processes won’t just keep you compliant. It will also show how your investment in CM leads to more reliable, higher quality products, which is good for your customers and your business.