The implementation of process analytical technology(PAT) in a commercial active pharmaceutical ingredient(API) recrystallization production process was introduced in this paper

in which the near infrared(NIR) spectroscopy technology was used to monitor the concentration adjustment process under the requirements of good manufacturing practice(GMP).The hardware and software of the monitoring system were qualified according to the requirements of a complex computerized system.Two prediction models for API concentration and moisture were developed by partial least square(PLS) algorithm

which performance was evaluated by root mean square error of calibration(RMSEC)

root mean square error of cross validation(RMSECV)

root mean square error of prediction(RMSEP) and determination coefficient(R2)

respectively.In order to ensure the performance of the models

the linearity

range

accuracy

precision(repeatability)

specificity and robustness were verified again according to the analytical method verification requirements.Finally

the system performance was tested to confirm that the PAT system meets the requirements for commercial operation.PAT control of the concentration adjustment process could greatly shorten the concentration adjustment time

save the steam energy consumption and testing costs

reduce the deviation of production

increase the consistency of different batches

and improve the product quality.