Pharmaceutical manufacturers face various tough regulations. Releasing failures to the market can be disastrous. For this reason, inspection sometimes need to be 100 %. At the same time batches can be very large. This can be a real challenge.
Chemometrics really is the panacea for pharmaceutical production. Handling large data sets combining fast measurements, make it possible to positively verify milions of tablets, if needed.
Of course measurements need to meet the pharmaceutical industry’s strict hygiene requirements and QC data needs to meet 21 CFR Part 11.
Pharmaceutical companies have increasingly integrated quality control into the production process through Process Analytical Technology (PAT). In-line measurements guarantee that the variation of semi-manufactured and final products stay within set limits.