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ASTM E 2476 : 2016 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Available format(s)

PDF

Superseded date

23-12-2022

Language(s)

English

Published date

17-11-2016

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2016 Gives guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry.

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.

Committee
E 55
DocumentType
Redline
Pages
10
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM E 3106 : 2017 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
ASTM E 2891 : 2013 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2898 : 2014 : REDLINE Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 2629 : 2011 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

IEC 61025:2006 Fault tree analysis (FTA)
ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ISO 22000:2005 Food safety management systems Requirements for any organization in the food chain
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

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