The best closed granulation line supplier in China is not simply the one with the lowest quotation. ICH Q8 asks whether equipment design supports process understanding and consistent product quality. For a closed line, examine sealed powder transfers, sampling points, air handling, and cleaning access. Ask for test records, not just polished drawings. That matters.
ICH Q9 gives qualification a risk-based structure. Map failure points, such as transfer leaks, sensor drift, and incomplete cleaning, then check how the supplier detects and controls them. The FDA’s 2019 report, Drug Shortages: Root Causes and Potential Solutions, attributed 62% of reported shortages to manufacturing and quality problems. The figure is not specific to granulation, but it shows why equipment reliability deserves scrutiny.
ICH Q10 extends the review beyond installation: assess change control, deviation handling, corrective actions, and support after handover. Request traceable factory and site acceptance tests, calibration records, and practical operator training. One uncomfortable point: a complete document pack can still miss a weak service response. Qualification should test that, too.
A supplier’s promises are not evidence.
I would keep the final decision open until the line’s actual risks, records, and support arrangements have been checked.