Guidance Documents

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

GAMP Guide: Artificial Intelligence

Just Published - 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.

Good Practice Guide: Validation 4.0

Recently Published - As pharmaceutical manufacturing evolves, Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing Artificial Intelligence (AI), Internet of Things (IoT), cloud computing, and digital twins. This approach involves integrating Quality by Design (QbD), Quality Risk Management (QRM), and digital technologies to create a Holistic Control Strategy (HCS) that spans the entire product lifecycle. This Guide builds on the concepts as discussed in the ISPE Baseline® Guide: Pharma 4.0™ by providing an overview of the objective of validation in the pharmaceutical industry and moves into a holistic view of demonstrating control through digitization and digitalization and doing so in a continuous cycle.

Good Practice Guide: Digital Validation

Recently Published - 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.

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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.

Handbooks

Handbooks provide a comprehensive ready reference, with concise information on a particular topic, occupation, or process. They are structured to give quick answers in specific topic areas.

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  • - The contents of ISPE’s guidance documents, both printed and digital, 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. 

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Increased Access to 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.