PAT & QbD SUPPLEMENT


in-process materials and final product, with the goal of ensuring final product quality. PAT implementation’s main aim is to enhance manufacturing process understanding and when necessary to be used for continuous monitoring and control. The use of Process Analytical Technologies (PAT) has been of


great benefit to pharmaceutical companies providing better knowledge of raw materials, manufacturing process, critical parameters and their impact on finished product quality. In general, PAT approaches in Pharma industries help to:  Increase process understanding through fast, timely measure ments during manufacturing


 Optimise processes and define design space  Aid in process scale-up activities and technology transfer from R&D to manufacturing


 Aid in defining and justifying the control strategy for manufacturing processes


 Monitor continuously the quality of raw materials, in-process and/or final product


 Reduce in-process checks  Detect deviation and abnormalities  Continuously diagnose the processes and equipments performance


 Reduce manufacturing cycle time, waste and cost improving sustainability2


 Enhance regulatory submissions for faster drug application approvals through competitive advantages in process monitoring and control as described in the FDA’s requirements for PAT and cGMP for 21st Centuryguidelines1


.


increase process understanding and control, hence increasing the probability of meeting the FDA desired state, to help in the submission of new products”


“The value of using PAT tools is mainly to


Multivariate data analysis is another key component of defining QbD in the pharmaceutical industry. According to ICH Q83


:


‘The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality’. ‘A design space can be described in terms of ranges of material attributes and process parameters, or through more complex mathematical relationships. It is possible to describe a design space as a time dependent function (e.g., temperature and pressure cycle of a lyophilisation cycle), or as a combination of variables such as components of a multivariate model.’ Multivariate analysis is also a must when using PAT technologies.


It is needed in the analysis of the PAT data in order to provide on-line process models.


Review of PAT applications in pharmaceutical development PAT is widely used in the pharmaceutical development of manufacturing processes for drug substances (i.e. reaction, crystallisation, distillation, drying) and drug products (suspension, granulation, blending, compression, coating, filling, micronisation) of


European Pharmaceutical Review www.europeanpharmaceuticalreview.com Volume 16 | Issue 3 | 2011


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