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 65 Guidance Documents covering a wide variety of topics. Below are the coming soon and latest Guides.
Coming Soon
Baseline Guide Volume 8: Pharma 4.0™ (First Edition)
Questions on starting or re-starting your digital transformation? We’ve got answers. Digital transformation stalled? Deciding where to start your transformation journey? We can help. Research shows that 70% of digital transformations fall short of their objectives. We can help you turn that around.
Published: November 2023
Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities (Third Edition)
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.
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Published: October 2023
Good Practice Guide: Process Gases (Second Edition)
Presenting recent advances in construction materials and updates on current good practices, this edition is aligned with the latest guidance, such as the newly revised Annex 1 and the ISPE Baseline® Guide: C&Q (Second Edition). Topics discussed include contaminant reduction, sustainability requirements, and medical gases regulations.
Published: August 2023
Guide: 503B Compounding – Regulatory Basis & Industry Good Practices for Outsourcing Facilities
Struggling to understand 503B outsourcing facilities regulations? This Guide is your go-to resource for practical guidance on aseptic practices and facilities appropriate for your scale of manufacturing. Combining information from applicable regulations and guidances with industry good practices, this ISPE Guide provides the reader with the tools and rationale for implementing effective processes.
Published: December 2022
Good Practice Guide: Containment
Containment involves many different disciplines, concepts, and technologies to protect the product, people, facility, and environment. One of the objectives of this Guide is to consolidate this knowledge into one document that describes and discusses the methodologies, processes, and technologies commonly used in the pharmaceutical industry.
Published: November 2022
APQ Guide: Cultural Excellence
Cultural excellence is fundamental to the delivery of sustained quality and performance improvement. It acts as the foundation for the PQS elements described in ICH Q10. The ISPE APQ Guide: Cultural Excellence provides a systematic approach to assessing and advancing an organization’s culture of quality.
Published: September 2022
APQ Guide: Process Performance and Product Quality Monitoring System
The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of the PQS described in ICH Q10. An effective PPPQMS ensures a state of control is maintained and facilitates continual improvement. The ISPE APQ Guide: PPPQMS provides a quality management framework for assessing and advancing an organization’s PPPQMS.
Published: July 2022
GAMP® 5 (Second Edition)
Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.
Published: May 2022
Good Practice Guide: Membrane-Based Water for Injection Systems
Membrane-based based technologies for producing WFI have been in existence for over 20 years but have only recently been widely accepted around the globe. The recent acceptance of these technologies by the European Pharmacopoeia along with most other pharmacopeias has served as the driving force behind this Guide.