ASTM E 2476 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Hardcopy , PDF
17-08-2023
English
17-11-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry
| Committee |
E 55
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| DocumentType |
Guide
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| Pages |
10
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
1.1This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Practice E2474, Guide E2500, and ICH Q8.
1.2This 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. Note that safety in this context refers to operational and operator safety, not to patient safety.
| ASTM E 2629 : 2019 | Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems |
| ASTM E 2898 : 2014 | Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications |
| ASTM E 2500 : 2013 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 3106 : 2018 : EDT 1 | Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation |
| ASTM E 2474 : 2014 | Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020) |
| ASTM E 2891 : 2013 | Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications |
| ASTM E 2891 : 2020 | Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications |
| ASTM E 2629 : 2020 | Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems |
| ASTM E 2898 : 2020 : REV A | Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications |
| ASTM E 2500 : 2020 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2363 : 2005 | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2363 : 2005 : REV B | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2500 : 2020 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2500 : 2007 : R2012 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2500 : 2007 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2474 : 2014 | Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020) |
| ASTM E 2363 : 2004 | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2363 : 2006 | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2474 : 2006 | Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology |
| ASTM E 2500 : 2013 | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ASTM E 2363 : 2004 : REV A | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2363 : 2005 : REV A | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2363 : 2006 : REV A | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2363 : 2014 | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
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