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What you need to know about the GAMP track: 2024 ISPE Europe Annual Conference, 16 – 18 April

Frank Henrichmann
Heather D. Watson
What you need to know about the GAMP track

The ISPE GAMP® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and discussed at the 2023 ISPE Europe Annual Conference, the 2023 ISPE Annual Meeting & Expo, and at several local GAMP events held around the globe.

The upcoming 2024 ISPE Europe Annual Conference will provide an excellent opportunity to participate in a data integrity workshop moderated by Shikha Raikundalia (Integrity) and Petch Ashida Druar (Syneos Health). This workshop, set to take place before the conference begins, will provide hands-on challenges and exercises. The conference will feature guidance on GAMP 5 and its applications, provide opportunities for peers and regulators to discuss the guide's content, and empower attendees to ask questions.

2024 ISPE Europe Annual Conference

The need for validation approaches to effectively manage risks to patent safety, data integrity, and product quality becomes increasingly vital – especially as the pharmaceutical industry embraces advancing technologies amid emerging challenges such as pandemics, supply chain disruptions, and drug shortages. It is essential that computer system validation does not hinder innovation; instead, it should serve as a facilitator, ensuring systems are well-suited for their intended purpose without imposing unnecessary documentation burdens. The conference tracks will also highlight new concepts such as critical thinking as it applies to testing applications, as well as new technological improvements and software development methods like agile.

The objective is to ensure that investments in novel solutions enhance the quality and efficiency of developing, manufacturing, and distributing treatments. Validation, therefore, transcends mere template-filling and checklist completion; it involves thoughtful consideration, robust risk assessment, and well-justified decision-making.

The GAMP track will be hosted by members of the GAMP Global Steering Committee: Frank Henrichmann (Co-Chair), Heather Watson (Immediate Past Chair), Shikha Raikundalia, and Thomas Carganico. It will also include presentations from industry thought leaders and subject matter experts.

The GAMP track will kick off on Wednesday, at 1345 WEST (UTC+1)/0845 EST on 17 April, with a discussion panel featuring representatives from international regulatory agencies, including the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA). They will discuss the implications of recent regulations and guidelines on the industry. The panel will be hosted by Khaled Moussally (Compliance Group).

This will be followed by a presentation on how to leverage GAMP 5 Second Edition for medical devices. Ralph Dröge will identify and introduce relevant medical device standards for software as/in medical devices and explain how GAMP 5 principles and methods can be applied to medical devices.

Then we will have a closer look at best practices for digital batch records, provided by Gilad Langer (Tulip), Jörn Volckmann (FrontWell Solutions GmbH), and Michelle Vuolo (Tulip). They will demonstrate how using digital tools for batch recording and digitization of GMP processes and procedures can significantly reduce efforts. They will also elaborate on how digital solutions can provide easily accessible and interpretable documentation.

Afterward, subject matter experts will address challenges in supplier management. Shikha Raikundalia (Integrity) will speak about supplier qualifications. She will highlight key aspects and critical considerations in terms of qualifying technology suppliers and service providers. The GAMP track on Wednesday, 17 April, will conclude with a presentation by Yves Samson (Kereon) with a focus on challenges with implementing e-compliance requirements for suppliers and service providers.

Thursday, 18 April, starting at 0900 WEST (UTC +1)/0400 EST, the GAMP track will shift its focus to artificial intelligence (AI). The first session will outline how to adopt systems for the regulatory industry, as AI will undoubtedly have an enormous impact on equipment, systems, and processes in the industry. Don’t miss the session in which Stefan Münch (Körber Pharma Consulting GmbH) and Brandi Stockton (The Triality Group) will introduce a control framework to limit the risk of AI in good practice quality guidelines and regulations (GxP). This will enable organizations to transition their AI/ML-based applications from research and development to GxP – while simultaneously managing, monitoring, and mastering the associated risks. The application of the framework will be supported by a risk analysis and mitigation matrix (RAMM) and illustrated by an example highlighting data synthesis and model validation.

Then Mario Holl (CSL Behring) will present a use case showing how AI revolutionized visual inspections at CSL Behring. Holl will highlight the quality and economic impact of the technical solution in this real-world example of applying AI to a vaccine product at CSL Behring. The solution condenses and synthesizes the expert knowledge of vision specialists in AI models and makes it available to AVIs to improve visual inspection-based decision-making. The AI topic will conclude with a presentation by Danilo Neri (PQE Group) and Michele Cianchini (Takeda Italy) on an AI-based automatic trend analysis system that has been designed and implemented to allow the automatic evaluation of environmental trends (e.g., water points, cleanrooms) acquired from a laboratory information management system database.

Several regulatory guidance documents have been issued in the last years, most noteworthy, the EMA’s “Guideline on computerized systems and electronic data in clinical trials.” These documents, along with the release of GAMP 5 Second Edition, have triggered an update of the GPG on Validation and Compliance of Computerized GCP Systems and Data that will be published in 2024.

Key experts involved in that update are Petch Ashida Druar (Syneos Health), Brandi Stockton (The Triality Group), Frank Henrichmann (QFINITY), and Thana Subramanian (Integrity), who will introduce, present and discuss real-world data, real-world evidence, and decentralized clinical trials, two areas in good clinical practice (GCP) that become increasingly important in the development of medicinal products. The specific challenges and approaches in quality and validation management of the systems supporting these areas will be presented and discussed.

Data integrity is the key quality aspect of clinical development. Thomas Koch (WTKoch GCP QA Consulting) will explore the challenges in data ownership for records progressing through the clinical data life cycle and transitioning across business processes and/or between suppliers, service providers, and, ultimately, the sponsor. He will present a practical data stewardship framework that ensures data integrity and comprehensive data governance across the complex clinical data life cycle that necessarily crosses multiple entities, systems, databases, and actors.

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