ASTM E3424-25

1.1 This guide provides guidance on the development, validation, and implementation of advanced process control (APC) methodologies in a good manufacturing practice (GMP) pharmaceutical environment.

1.2 The intention of the guide is to increase the awareness of information and approaches for APC. This guide covers numerous aspects to consider when determining whether to implement an APC-based application with respect to the use case, technology components, development, implementation, and validation of an APC system. It is not intended to outline a specific practice to be followed.

1.3 There are previous ASTM guides that cover continuous quality verification (Guide E2537) or verification activities to ensure that a PAT-enabled control system is fit for purpose (Guide E2629). The scope of this guide however, is to help a user with a process that has potential for APC, understand if there is need or business case for an APC application and understand the components and the process involved.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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.