Standard Guide for Development and Validation Considerations of Advanced Process Control (APC) in Commercial Pharmaceutical Manufacturing

Importancia y uso:

5.1 APC is the foundation to smart manufacturing. Smart manufacturing has emerged as one key concept as the industry transitions to an Industry 4.0 paradigm. FDA has also recognized this industry trend and published a perspective paper on Industry 4.0 in the International Journal of Pharmaceutics (3). SMLC defines smart manufacturing as “the intensified application of advanced intelligence systems to enable rapid manufacturing of new products, dynamic response to product demand, and real-time optimization of manufacturing production and supply chain networks.” APC is a critical component in this drive towards smart manufacturing, as traditional PID control is typically not sophisticated enough to handle the rapid, real-time optimization and high-quality requirements for a smart manufacturing process.

5.2 Some application examples are provided in Appendix X1 to illustrate practical significance and benefit of implementing APC. Although APC applies to both continuous and batch processes, most of the provided examples are for batch processes. As the industry moves towards continuous manufacturing, more examples of APC are expected.

Subcomité:

E55.13

Volúmen:

14.01

Palabras clave:

advanced process control; APC; development; lifecycle management; validation;