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ASTM E 2500 : 2013 : REDLINE

ASTM E 2500 : 2013 : 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

Available format(s)

PDF

Superseded date

11-17-2020

Language(s)

English

Published date

11-01-2013

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2016 Applies 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.

1.1This 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.

Committee
E 55
DocumentType
Redline
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
ASTM E 3051 : 2016 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
ASTM E 3077 : 2017 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
ASTM E 3077 : 2017 : EDT 1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
ASTM E 2898 : 2014 : REDLINE Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
ASME BPE : 2016 BIOPROCESSING EQUIPMENT
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ASTM E 2476 : 2016 : REDLINE Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
VDI 2083 Blatt 13.3:2010-10 Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications
UNE-EN ISO 15378:2016 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
14/30287226 DC : 0 BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ASTM E 2629 : 2011 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2656 : 2016 : REDLINE Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

ASTM E 2629 : 2011 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E 2363 : 2014 : REDLINE Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 2476 : 2016 : REDLINE Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E 2474 : 2014 : REDLINE Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
ASTM E 2537 : 2016 : REDLINE Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

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