ASTM E 2500 : 2007 : R2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
11-11-2014
English
15-10-2012
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
E 55
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| DocumentType |
Guide
|
| Pages |
5
|
| ProductNote |
Reconfirmed 2012
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
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| 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.
1.3This 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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