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Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

ASTM Volume 14.05 Statistical Methods, Hazard Potential of Chemicals

E2474-06 Publication Description:

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.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Pharmaceutics-General (11.120.01)

ICS Related Standards

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$46.00 E2363-14 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
$49.20 E2363-06a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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$49.20 E2363-05b Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
$49.20 E2363-05a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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$49.20 E2363-04a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
$49.20 E2363-04 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
$41.00 E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
$46.00 E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
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$49.20 F619-79(1997)e1 Standard Practice for Extraction of Medical Plastics
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$49.20 F624-98a(2003) Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
$49.20 F624-98a Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
$49.20 F624-98ae1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
$41.00 F639-09(2015) Standard Specification for Polyethylene Plastics for Medical Applications
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$49.20 F639-98a(2003) Standard Specification for Polyethylene Plastics for Medical Applications
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$49.20 F640-07 Standard Test Methods for Determining Radiopacity for Medical Use
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$49.20 F702-98a(2003) Standard Specification for Polysulfone Resin for Medical Applications
$49.20 F702-98ae1 Standard Specification for Polysulfone Resin for Medical Applications
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$41.00 F997-10 Standard Specification for Polycarbonate Resin for Medical Applications
$49.20 F997-98a(2003) Standard Specification for Polycarbonate Resin for Medical Applications
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