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

ASTM E2474 - 14

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

Status : Current   Published : January 2014

Format
PDF

Format
HARDCOPY



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.




Standard NumberASTM E2474 - 14
TitleStandard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
StatusCurrent
Publication Date04 January 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Design space, Desired state, Manufacturing, PAT, Pharmaceutical process design, Process analytical technology, Process understanding, Quality risk management
ICS11.120.01
PublisherASTM
FormatA4
DeliveryYes
Pages3
File Size0 KB
Price£36.00


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