Guidance Documents

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

Published: October 2024 Pages: 156 Table of Contents Special Pricing for Emerging Economies This updated Guide offers comprehensive guidance on designing and operating pharmaceutical water storage and distribution systems that utilize ozone for
Published: September 2024 Pages: 272 Table of Contents Special Pricing for Emerging Economies Heating, Ventilation, and Air Conditioning (HVAC) systems can critically affect the ability of a pharmaceutical facility to meet its objective of providing
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
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
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.
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...
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).
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.
Published: November 2010 Pages: 124 Table of Contents Special Pricing for Emerging Economies The GAMP ® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management