ASTM E2500-13
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- Standard No.
- ASTM E2500-13
- Release Date
- 2013
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM E2500-20
- Latest
- ASTM E2500-20
- Scope
5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, and to satisfy requirements for design, installation, operation, and performance.
5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.
5.3 This guide supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10, and ICH Q11.
5.4 This guide may be used independently or in conjunction with other E55 standards published by ASTM International.
1.1 This 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.
1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.
1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.
1.4 This 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.
1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.
1.6 This 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 E2500-13 Referenced Document
- ASTM E2363 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
- ASTM E2474 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology*， 2024-04-20 Update
- ASTM E2475 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
- ASTM E2476 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
- ASTM E2537 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
- ASTM E2629 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
ASTM E2500-13 history
- 2020 ASTM E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- 2013 ASTM E2500-13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- 2007 ASTM E2500-07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- 2007 ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
