Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, real-world information you need to help your company build on current best practices to meet and exceed regulatory standards. ISPE Members receive a discount on Guidance Documents.
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Featured Guidance Documents
Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases 2nd Edition
Just Published - This revision is a comprehensive guide to pharmaceutical utility sampling, addressing the complexities of collecting representative samples from water, steam, compressed air, and process gases, outlining the differences of sampling for “process control” as opposed to sampling for “quality control”. This Guide applies to manufacturers of pharmaceuticals, medical devices, biologics, cosmetics, and related products as well as equipment manufacturers and vendors.
Guide: Quality Risk Management
Just Published - The revised ICH Q9(R1) has redefined expectations for Quality Risk Management, and this new ISPE Guide will show how to apply these principles and tools. Grounded in regulatory guidance and industry experience, this Guide supports more effective QRM, a stronger Pharmaceutical Quality System (PQS) and improved product availability for patients.
GAMP Good Practice Guide: GxP Process Control Systems 3rd Edition
Just Published - This revision adds information on modular systems/plants, software tools, cloud and SaaS interfaces, cybersecurity, and AI, along with leveraging C&Q activities during computerized system validation. The content, aimed at regulated companies and suppliers, has also been aligned with recently published ISPE GAMP® Guides, including ISPE GAMP® 5 (Second Edition).
Recently Published Guidance Documents
GAMP Guides and Good Practice Guides.
GAMP® guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. It aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements by building upon existing industry good practice in an efficient and effective manner. GAMP® adopts a patient-centric risk-based approach that enables innovation while demonstrating compliance with regulatory requirements.
Good Practice Guides
Reflecting current regulatory expectations and best practices, Good Practice Guides (GPGs) help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.
Baseline® Guides
Created with input from various global regulatory agencies, Baseline® Guides are intended to establish a compliant minimum acceptable (baseline) approach to the topic area. They typically focus on the “what”.
Guides
Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.
APQ
The APQ Guides series proves a set of tool and systematic approaches – the Assess, Aspire, Act, and Advance Framework – for organizations to advance the maturity and effectiveness of these PQS elements.
PQLI
ISPE’s Product Quality Lifecycle Implementation (PQLI)® initiative was created to provide guidance on practical implementation of the concepts described in ICH guidelines, focusing on ICH Q8, Q9, Q10, Q11 and Q12 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement. The original project produced the ISPE PQLI® Guide Series.
SOP Templates
These SOP Templates are designed to help organizations document, implement, and maintain quality processes that meet global standards such as FDA, EMA, ICH, and WHO. Whether establishing a new Quality Management Systems (QMS) or refining an existing one, these templates provide a structured, audit-ready format to ensure quality procedures are clear, consistent, and compliant.
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Guidance Document License Agreement
- - The contents of ISPE’s guidance documents are protected by law and intended solely for the personal non-commercial use of the individual purchaser.
- - Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.
- - Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.
Increased Access to Good Practice Guides Access to ISPE Good Practice Guides
With an ISPE membership, you'll gain viewing access to 25+ select Good Practice Guides.
GAMP Good Practice Guides are excluded from this member benefit.
