Guidance Documents

Information about ISPE's Guidance Documents, white papers, Knowledge Briefs and other written technical guidance.

Guides

Guide: 503A Compounding

Published : April 2024 Pages : 72 Table of Contents Special Pricing for Emerging Economies Following the need identified by the ISPE survey of compounding pharmacies and regulators, it is evident that compounding pharmacies would benefit from
Guides

Guide: ATMPs - Allogeneic Cell Therapy

Published: January 2024 Pages: 144 Table of Contents Special Pricing for Emerging Economies Advanced Therapy Medicinal Products (ATMPs) are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific
Baseline Guides

Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition

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.
Guides

Guide: 503B Compounding

Published: August 2023 Pages: 122 Table of Contents Special Pricing for Emerging Economies An ISPE survey of compounding pharmacies and regulators overwhelmingly demonstrated that 503B outsourcing facilities could benefit from comprehensive guidance
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Introducing the Future of ISPE Guidance Documents At ISPE, our mission has always been to connect knowledge, operational excellence and regulatory insights. In keeping with this commitment, we are excited to announce...
Good Practice Guides

Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities.
Good Practice Guides

Good Practice Guide: Good Engineering Practice 2nd Edition

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP.
Good Practice Guides

Good Practice Guide: Knowledge Management in Pharmaceutical Industry

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM).
Good Practice Guides

Good Practice Guide: Membrane-Based WFI Systems

The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.