ASTM-E2476 2009

$40.63

E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

Published By	Publication Date	Number of Pages
ASTM	2009	11

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Categories: 11.120.10 - Medicaments, ASTM

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Description

1.1 This 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 E 2474 , Guide E 2500 , and ICH Q8.

1.2 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. Note that safety in this context refers to operational and operator safety, not to patient safety.

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PDF Pages	PDF Title
1	Scope
2	Referenced Documents Terminology Significance and Use Principles of Risk Assessment and Risk Control
3	Preparation for Risk Assessment and Risk Control
4	Application of Risk Assessment and Risk Control to PAT FIG. 1
6	Use of Risk Assessment to Determine Critical Quality Attributes and Critical Control Parameters for a PAT Process
7	FIG. 2
8	Use of Risk Assessment to Evaluate Control in PAT Processes Keywords
9	X1. INFORMATIVE GUIDE TO METHODOLOGIES SUPPORTING RISK ASSESSMENT X1.1 X1.2 X1.3 X1.4 Identification of Risk Factors FIG. 3
10	X1.5 X1.6

Additional information

Standard Title	E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
Published Code	ASTM
Publication Date	2009
Pages Count	11
ICS Codes	11.120.10 - Medicaments

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ASTM-E2476 2009

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