Assuring manufacturing and data integrity for cell and gene therapy regulatory compliance

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Data integrity has become a major challenge to the pharmaceutical industry as equipment becomes increasingly computerized. Data is no longer represented by a simple printout or a value on the screen; instead it consists of many parameters and calculations and can, in some cases, even be re-processed to display result differently. All the data we create during product manufacturing and analysis must maintain its integrity and follow ALCOA plus principles throughout the life cycle of the product. Reliable data is key in guaranteeing that products are safe for patients. To ensure this, computerized systems are used to generate data and are these systems must undergo validation to demonstrate they are fit for purpose.

Computerized Systems Validation (CSV) consists of documented evidence that a computerized system adheres to ALCOA plus principles. Ensuring this adherence to through technical controls is challenging and often quite complex and time-consuming. The requirements to meet ALCOA plus come from 21 CFR Part 11 (FDA) and Eudralex GMP Annex 11 (EU), and apply to all computerized systems. As these are interpreted by the manufacturers of such computerized systems and translated into technical capabilities built into the systems, differences in the capability of meeting these principles inevitably arise, which carries challenges for the companies using them in GMP settings.

How to bring regulatory requirements for computerized systems and data integrity into practice.
How to ensure data integrity when using computerized systems.
Technical challenges and solutions when using computerized systems in the field of CGT

Jelena Jurlin

Head of Compliance, Lonza

Jelena holds a Master’s degree in Molecular Biology and has been in the pharma industry since 2013. Her career began within the Microbiological Quality Control Laboratory at Teva in Zagreb, Croatia, where she carried out routine microbiological testing, method validation, and technology transfer before establishing a biological laboratory within Quality Control in 2015. She also led With increased focus in data integrity, she led gap assessment of computerized systems within Quality Control and Manufacturing and designed site remediation plan for Teva's sites.

In 2017, Jelena relocated to The Netherlands, working for Lonza in the field of cell and gene therapy, where her work evolved towards Quality Assurance, and where she leads the CSV team and site remediation to ensure data integrity. In April 2021, she became Head of Compliance, additionally overseeing the quality system team.

Dr. Dmitry Fridman

Global Product Manager, Miltenyi Biotec B.V. & Co. KG

Dmitry is responsible for Miltenyi Biotec’s data acquisition and analysis software MACSQuantify™, which is used with its MACSQuant® Instruments. Over the last two years, he has concentrated on helping meet the validation requirements for computerized systems in flow cytometry instruments across many industrial projects in the highly regulated GMP environment. These mainly circled around data integrity requirements according to ALCOA++ principles, 21 CFR Part 11 & Eudralex Annex 11 regulations, as well as operating system and connectivity requirements

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