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: Quality Lab Facilities

ISPE has produced the industry’s first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications.
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: Operations Management

For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems for getting work done. The ISPE Good Practice Guide: Operations Management aims to provide the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management.
Good Practice Guides

Good Practice Guide: Process Validation

The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.