ASTM E2474-14 PDF

Scope: 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), or

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

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.

1.5 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.

ASTM E2474-14 Referenced Document

ASTM E1325 Standard Terminology Relating to Design of Experiments
ASTM E2475 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
ASTM E2476 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E2587 Standard Practice for Use of Control Charts in Statistical Process Control*， 2024-04-20 Update
ASTM E2629 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

2014 ASTM E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
2006 ASTM E2474-06 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology