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, for example, qualified, 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, ICH Q11, ICH Q12, and ICH Q13.

5.4 This guide is designed to conform with FDA Guidance for Industry Process Validation, EU GMP (Annex 11 and 15), and other international regulations regarding equipment and facility suitability for use and qualification.

5.5 This guide may be used independently or in conjunction with other Committee E55 standards published by ASTM International.

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 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.

1.8 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.