Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to stay current with industry best practices and regulatory expectations.
ISPE has more than 80 Guidance Documents covering a wide variety of topics. Below are the coming soon and latest Guides.
Coming Soon
GAMP Guide: Artificial Intelligence
This Guide provides a holistic view on developing and using AI in GxP areas effectively, while safeguarding patient safety, product quality, and data integrity. It aims to support alignment among diverse stakeholders to seize benefits of quickly advancing technology by overcoming challenges in the management of the AI-enabled system life cycle.
Coming Soon
Good Practice Guide: Digital Validation
The transition from traditional, paper-based validation to a digitally integrated framework remains a complex challenge. This Good Practice Guide considers how increased adoption of Digital Validation Tools (DVTs) in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance. Developed by a global team of experts in validation, regulatory compliance, quality assurance, and digital transformation, this Guide presents real-world insights, case studies, and structured methodologies to facilitate the successful integration of digital validation into business operations.
Published: December 2024
Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
Retitled and revised, the new edition covers the lessons learned from numerous containment performance assessments conducted by pharmaceutical industry professionals following the criteria outlined in the Guide. This was originally titled ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment.
Published: October 2024
Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage & Distribution Systems 2nd Edition
This updated Guide provides direction for companies considering implementation of an ozone system for sanitizing a high-purity GMP pharmaceutical water storage and distribution system. As with other sanitization methods, ozone technology imposes specific requirements on system design and operation, which may impact the chemical properties of the water. The purpose of this document is to assist in the evaluation, design, and implementation of these ozone systems.
Published: September 2024
Good Practice Guide: Heating, Ventilation, & Air Conditioning 2nd Edition
This updated Guide aims to clarify GMP HVAC issues affecting the safety, quality, identity, potency, and purity of pharmaceuticals, biopharmaceuticals, advanced therapy medicinal products, and medical devices from raw materials to finished products. It outlines requirements for HVAC control and monitoring while addressing current advancements in technology and evolving project demands, such as increased sustainability requirements and accelerated construction timelines.
Published: July 2024
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
This updated Guide is a valuable resource for all stakeholders involved in the validation of GCP computer systems. By fostering a robust validation framework, it aims to support the integrity and efficiency of clinical trials, ultimately contributing to the advancement of medical science and the development of new therapies.
Published: May 2024
Good Practice Guide: Unique ID of Glass Primary Containers
Seeking solutions to unique identifiers for primary parenteral containers? Created by a cross section of industry experts in the parenteral/injectable medicine manufacturing industry, the Guide outlines best practices for developing, implementing, and managing traceability projects.
Published: April 2024
Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies
Struggling to understand 503A compounding regulations? This Guide is your go-to resource for compounding sterile and nonsterile preparations. Combining information from multiple USP chapters with industry good practices, this ISPE Guide provides the reader with the tools for implementing safe compounding practices.