Baseline Guides

The Guide covers all areas of transformation including the benefits of a holistic control strategy, opportunities opened by digital transformation in quality management, and the foundational processes and principles for interconnected plant architecture. It includes organizational change management practices to help workers adapt to confounding challenges from new technologies and acquire the necessary skills to thrive in a changing culture. Readers will discover strategies that are revolutionizing facility design including simulation and virtualization are presented.

The biopharmaceutical industry has adapted to reflect available technologies such as single-use technologies and modular construction methodologies, products with more focused patient populations, evolving regulatory conditions, unrelenting pressures on costs, and increased focus on robust product supply while maintaining high-quality standards. This Guide presents concepts that reflect how these changes affect biopharmaceutical manufacturing facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.

This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical Chemicals). The ISPE API Baseline Guide also incorporates and builds on new regulations and guidance

The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for regulatory interpretation, while still allowing a flexible, innovative, and compliant approach to facility design, construction, commissioning, and qualification. This approach is intended to allow manufacturers to better serve their customers by helping reduce costs and improve product quality.

The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, for managing the risk of cross-contamination within shared facilities. Risk management processes should be used to determine and document reasonable and acceptable risk, in order to maintain product quality and operator safety and to satisfy regulatory requirements.

The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.

This Guide intends to offer a compliant, integrated C&Q approach to making the qualification process efficient and cost-effective. This approach includes a System Risk Assessment process that identifies Critical Aspects and Critical Design Elements. This Guide recognizes industry best practices regarding C&Q and presents concepts that can assist organizations in meeting current regulatory expectations for system qualification.

The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers engineering aspects of designing new sterile products manufacturing facilities and modifications of existing facilities. The Guide focuses on how to provide cost-effective facilities which make best use of available modern technologies to ensure that products of the highest quality are consistently manufactured.