Designation

This standard is issued under the fixed designation E2500; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (ε) indicates an editorial change since the last revision or reapproval.

1. Scope

1.1

This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality, availability, and/or 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, medical device manufacturing systems (laboratory instrument qualification is covered in USP <1058>), and information (software qualification is covered by ISPE GAMP Series documents; risk management of medical device manufacturing is covered in ISO 14971).

1.4

This guide is applicable to both new and existing manufacturing systems. The approach may be used for implementation of changes to existing systems.

1.5

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

1.6

The impact of quality risk management for an entire facility (such as contamination control strategy (CCS)) is not a part of the scope and subject to separate assessments; however, the outputs from these exercises could serve as inputs to the process risks and/or risk mitigations that may be subsequently used in assessments of manufacturing systems.

1.7

This standard does not address employee health andsafety, 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, health, andenvironmental practices and determine the applicability of regulatory limitations prior to use.

1.8

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

2.1

2.2

2.3

2.4

3. Terminology

4. Summary of Guide

4.1

4.2

4.3

4.4

4.5

4.6

5. Significance and Use

5.1

5.2

5.3

5.4

5.5

6. Key Concepts

6.1

6.2

6.3

6.4

6.5

6.6

6.7

6.8

6.9

7. QRM Based Commissioning and Qualification Process

7.1

7.2

7.3

7.4

7.5

8. Commissioning and Qualification Enablers

8.1

8.2

8.3

8.4

9. Keywords

9.1

ASTM E2500 - 25

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach

Current

Published:

15 Mar 2025