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.
Quick Links:
- Guidance Documents Portal
- Corporate Subscriptions
- Translations
- Guidance Documents Teams
- Guidance Documents FAQs
Featured Guidance Documents
Good Practice Guide: Pharma 4.0™ – Holistic Digital Enablement
Just Published - This Guide provides a comprehensive framework and set of good practices to support holistic digital enablement in Pharma 4.0™. It is geared toward a wide range of stakeholders involved in the digital transformation journey, offering insights into best practices for aligning and optimizing digital initiatives in a flexible, scalable approach.
Good Practice Guide: ATMPs – Equipment Design & Qualification for Cellular Products
Just Published - This Guide delivers practical, expert-driven insights into the selection and qualification of equipment for cellular therapy manufacturing. Focused on autologous and allogeneic therapies, it addresses key challenges in aseptic processing, automation, and scalability. Aligned with global regulatory standards, it supports both manufacturers and vendors in advancing closed, automated, and cost-effective solutions that improve patient outcomes.
Good Practice Guide: Control Strategy Development for CM of OSD Forms
Just Published - Continuous manufacturing (CM) for oral solid dosages (OSD) is growing but the rate of adoption has been slowed down by infrastructure and cross-functional challenges. This Guide offers practical strategies for CM control, covering process modeling, spectroscopy, sampling, statistics, and regulations. It aims to streamline implementation, support lifecycle management, and encourage industry adoption by removing barriers during development and enhancing commercialization success.
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.
IP Publications
Affiliate Publications
Initiatives
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 access to 25+ Good Practice Guides.
GAMP Good Practice Guides are excluded from this member benefit.
