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.
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.
Published: January 2024
Guide: ATMPs - Allogeneic Cell Therapy
The development, regulatory path, facility design, qualification, and manufacture of ATMPs present significant challenges to manufacturers, engineers, and suppliers. The GMP regulations are evolving as novel processes are presented and manufacturing paradigms are being tested. This Guide addresses facility engineering issues that are most applicable at the time of publication, as based on the experience of the authors.
Published: January 2024
Guide: ATMPs - rAAV Comparability & Lifecycle Management
The ICH Q5E principles for demonstrating comparability of biological products are not fit for purpose for ATMPs, resulting in different approaches across the industry. The ISPE Guide: ATMPs - Recombinant AAV Comparability and Lifecycle Management provides current understanding and best practices on rAAV comparability exercises, offering manufacturers a standardized approach for developing process and product comparability strategies.