1.1This 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.

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

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

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

1.3The 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.

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

1.5This 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.