ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers.

A new ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment has been published that provides direction to industry on the implementation of a science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment, and associated automation are fit for intended use and comply with regulatory requirements.

The aim of the Guide is to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.

Specific implementation guidance is given on meeting the expectations of global regulators and is compatible with ICH documents (Q8 (R2), Q9, and Q10) and ASTM E2500-07.

The Guide will be of interest to those following the latest industry and regulatory initiatives, including:

• product and process understanding
• a science- and risk-based approach
• application of Quality by Design concepts

The approach described in this Guide focuses on establishing that which is critical for the process, product, and patient, and recommends verification strategies for confirming these critical aspects.

The activities described address the verification (or qualification) portion of the validation life cycle upon which process validation is built.