Since its publication in 2017, the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice has provided users with a robust validation framework to help support the integrity and efficiency of clinical trials. However, advancement and changes in technology, the volume of data collected, and new regulations necessitated an update.
The first edition provided solid guidance for applying the GAMP principles to clinical systems, but GCP is a very dynamic area and is always changing due to technology and what is possible. Then the pandemic blew everything apart.
because companies that were executing clinical trials had to figure out how to do a clinical trial if patients could no longer come to the clinical site, and there was a need for different technologies and approaches that are now well-established, but these come with new challenges and opportunities.”
What’s in the New Edition?
The second edition has been significantly expanded to address these challenges and opportunities. The Guide discusses the increased complexity of hybrid or participant-centric decentralized trials and offers best practices for managing this complexity, which is caused by various factors such as a greater reliance on contractor/subcontractor processes and the use of participant-owned digital health technologies and devices, for example, a smartphone.
Written by subject matter experts in the field and members of the GAMP Community of Practice, the Guide discusses the processes involved in clinical studies. It highlights the unique challenges of collecting data by investigators that is later processed and analyzed by sponsors and/or suppliers. The Guide then provides validation approaches for the varied systems used in each process. Additionally, it offers suggestions for developing common systems applicable to multiple studies to minimize customization while meeting the unique needs of the individual project that is a clinical study.
Although it has been extensively updated and aligned with current regulatory guidelines and the second edition of the ISPE GAMP® 5: A Risk-Based Approach to Com-pliant GxP Computerized Systems, the goal of the Guide remains the same: to provide a comprehensive framework that supports effective and efficient quality assurance of computerized systems and electronic data used in GCP environments, thereby safeguarding the rights, safety, and well-being of trial participants while ensuring the credibility and reliability of clinical data.
The ISPE Japan Affiliate held the “Young Professionals Seminar” to support the growth of recent graduates. Starting on 14 July 2023, this seminar spanned four sessions and took place at the Nihonbashi Life Science Building and Taiyo Pharma Tech Takatsuki Plant. Led by ISPE Emerging Leaders, the seminar aimed to cultivate the next generation of leaders in the pharmaceutical industry.
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