ASTM E 2500 : 2025

1.1This 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.

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

1.3This 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).

1.4This guide is applicable to both new and existing manufacturing systems. The approach may be used for implementation of changes to existing systems.

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

1.6The 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.

1.7This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.8This 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.