The theory of sampling (TOS) is now followed in the development of near infrared (NIR) spectroscopic methods for the pharmaceutical industry. TOS has been the guiding light for a two-step approach for spectroscopic composite sampling available for the development of real-time analytical methods for particulate-based industrial processes. The two-step spectroscopic sample composite has been used in the development of process analytical technology (PAT), an important regulatory initiative to improve the quality of pharmaceutical products. The two-step sample composite approach overcomes the low sample volume analysed by PAT methods; one of the key limitations to PAT implementation in the industrial production of particulate-based materials.
PAT methods need to be validated demonstrating their accuracy, precision, specificity and robustness. TOS provides a deeper understanding of these validation studies which involve discrete particulate material. The validation of PAT methods is now being performed considering both sampling and analytical errors, while practically all previous method validations only addressed the total analytical error (TAE) of these methods. This has been a crucial impediment for the field of chemometrics as well.
PAT is a key element of continuous manufacturing (CM) processes, which are considered an emerging technology capable of increasing the flexibility, agility and robustness of pharmaceutical processes while reducing their costs. The outflow of the continuous process is a 1D lot, and variographic analysis has been shown to discern process variation from sampling and analytical errors in pharmaceutical CM processes. Thus, variographic analysis is a process improvement tool with significant potential for improving CM processes. The possibilities for improving pharmaceutical manufacturing are enormous.
Romañach, R J, 2017. Theory of
Sampling – from missing link to key enabler for process analytical technology,
in Proceedings Eighth World Conference on Sampling and Blending , pp 63–68 (The Australasian Institute of Mining and Metallurgy: Melbourne).