This practice covers pharmaceutical process design utilizing process analytical technology, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding. The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development. The following practices and methodologies shall be done to attain desired state: risk assessment and mitigation; continuous improvement; process fitness for purpose; intrinsic performance assessment; manufacturing strategy; data collection and formal experimental design; multivariate tools; process analyzers; and process control.

1.1 This practice covers process design, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding.

1.2 The term process design as used in this practice can mean:

1.2.1 The activities to design a process (the process design), and/or

1.2.2 The outcome of this activity (the designed process).

1.3 The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development.

1.4 The principles in this practice apply during development of a new process or the improvement or redesign of an existing one, or both.

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 and health practices and determine the applicability of regulatory limitations prior to use.