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ASTM E 2500 : 2007 : R2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Superseded by

ASTM E 2500 : 2013

Language(s)

English

Published date

15-10-2012

€67.30
Excluding VAT

Committee
E 55
DocumentType
Guide
Pages
5
ProductNote
Reconfirmed 2012
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

1.1This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.

1.2For brevity, these are referred to throughout the rest of this guide as manufacturing systems.

1.3This guide may also be applied to laboratory, information, and medical device manufacturing systems.

1.4This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation.

1.5This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.

1.6This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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.

ASTM E 3077 : 2017 : EDT 1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2898 : 2014 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASTM E 3051 : 2016 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
ASTM E 2476 : 2016 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 2656 : 2016 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

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