GAMP 5 Guide 2nd Edition

Published: July 2022
Pages: 404

• Table of Contents
• Special Pricing for Emerging Economies

GAMP aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.

Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. It highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.

The ISPE GAMP Community of Practice (CoP) performs regular ongoing assessments and reviews of GAMP knowledge against current practices and regulatory and technology developments. ISPE GAMP 5 (Second Edition) therefore embraces and reflects:

• Increased importance of service providers, which includes encouraging regulated companies to maximize supplier involvement to leverage knowledge, experience, and documentation where possible
• Evolving approaches to software development, emphasizing that the GAMP specification and verification approach is not inherently linear but also fully supports iterative and incremental methods
• Increased use of software tools and automation to achieve greater control, higher quality, and lower risks throughout the life cycle

Furthermore, this Guide highlights the importance of applying “critical thinking” by knowledgeable and experienced SMEs when defining the appropriate approach for specific circumstances.

GAMP® 5 Guide, 2nd Edition: Top Takeaways

Discussion of current FDA activity on Computer Software Assurance (CSA) approaches and clear links to ISPE/GAMP guidance on Data Integrity (DI) have been added.

The Appendices have been expanded to incorporate new and evolving topics in the life sciences industry such as blockchain, Artificial Intelligence/Machine Learning (AI/ML), cloud computing, and Open-Source Software (OSS).

This Guide is intended for use by regulated companies, suppliers, and regulators. Suppliers include providers of software, hardware, equipment, system integration services, IT service providers, and IT support services, both internal and external to the regulated company.

Guide Core Team

Chris Clark

Director

TenTenTen Consulting Limited

Heather D. Watson

Director

TenTenTen Consulting Ltd

Sion Wyn

Director

Conformity Ltd.

Mr. James Canterbury

Founder, CEO

Zeroth Technology Inc

Mr. Mark R. Cherry

IT Compliance Director

AstraZeneca

Frank Henrichmann

Senior Executive Consultant

Q-FINITY Quality Management

Mr. Paul J. Irving, BSc Hons

Managing Director

Northern Life Sciences Ltd.

Arthur D. Perez, PhD

Retired Director Information Governance and Management

Novartis Pharmaceuticals (retired)

Christopher J. Reid

CEO

Integrity Project Solutions Limited

Michael Rutherford

Principal, Computer Systems Quality & Data Integrity

Rutherford Consulting, LLC

Lorrie Vuolo-Schuessler

Retired

Retired

Eric. Staib

Vice President, Corporate Quality

Syneos Health

Thanabalan Subramanian

Head of Quality

Integrity

Charlie C. Wakeham

Director

WakeUp To Quality

Christopher White

Senior Director, Digital Integrity, QA

Formation Bio

Guy Wingate, PhD

Independent Consultant

GlaxoSmithLline PLC (Retired)