Continued Analytical Method Verification: Case Study

Aviv Cohen, MTS department, Company- Bio-Technology General Ferring, Be'er Tuvia , Israel (avco@ferring.com)

The pharmaceutical industry increasingly adopts a lifecycle approach to analytical procedures, emphasizing not only initial validation but also ongoing performance assurance. This approach is now regulated as Ongoing Procedure Performance Verification (OPPV) under USP <1220> and <1221>, and, more generally, under ICH Q14.

Continued Analytical Method Verification (CAMV) is a critical component of this paradigm. CAMV ensures that analytical methods remain fit for purpose throughout their routine use by applying risk-based monitoring, data trending, and proactive control strategies.

Implementation of CAMV involves statistical tools, periodic reviews, and integration with change control processes to detect variability and maintain compliance. CAMV is not merely a regulatory requirement; it is a strategic tool for sustaining analytical reliability in an evolving pharmaceutical landscape.

In addition, live trending of the control samples allows for a quick understanding of changes in method variability. Moreover, when these trends are viewed as an overlay on process data, we can quickly focus CPV OOT investigations on either the process or the analytics.

Ferring BTG has adopted this CAMV strategy to strengthen the robustness of our analytical assays. By leveraging lifecycle principles, risk-based monitoring, and trending analytics, we can achieve enhanced method control and reduced variability, ensuring consistent product quality.

Short Biography of Presenting Author

Aviv Cohen, Ph.D.

Senior Research Associate

Aviv Cohen is an accomplished biochemist with extensive experience in pharmaceutical, food-tech, and medical device industries. Holding a Ph.D. in Biochemistry from Tel Aviv University, Aviv’s doctoral research explored cellular aging mechanisms using Saccharomyces cerevisiae as a model system. During this period, Aviv collaborated across laboratories, managed research operations, presented at international conferences, and earned awards for both research and teaching excellence.

Currently serving as Senior Researcher and Data Analyst at BTG (Ferring), Aviv leads Continued Process Verification (CPV) and Continuous Analytical Method Verification (CAMV) initiatives, conducts process investigations, and applies advanced statistical analysis to support manufacturing operations. Aviv also manages local projects and global collaborations within Ferring.

Previously, Aviv was R&D Manager at Better Juice, a pioneering food-tech startup, where Aviv directed a team of researchers for their innovative sugar-reduction technology. Earlier, at Luminera LTD, a pharmaceutical medical aesthetic company, Aviv was an R&D Researcher and Lab Manager and developed a patented medical device.

Aviv has published multiple peer-reviewed articles on yeast aging and stress response and holds a European patent for advanced biomaterials.


Continued Analytical Method Verification: Case Study Aviv Cohen, MTS department, Company- Bio-Technology General Ferring, Be'er Tuvia , Israel (avco@ferring.com) The pharmaceutical industry increasingly adopts a lifecycle approach to analytical procedures, emphasizing not only initial validation but also ongoing performance assurance. This approach is now regulated as Ongoing Procedure Performance Verification (OPPV) under USP <1220> and <1221>, and, more generally, under ICH Q14. Continued Analytical Method Verification (CAMV) is a critical component of this paradigm. CAMV ensures that analytical methods remain fit for purpose throughout their routine use by applying risk-based monitoring, data trending, and proactive control strategies. Implementation of CAMV involves statistical tools, periodic reviews, and integration with change control processes to detect variability and maintain compliance. CAMV is not merely a regulatory requirement; it is a strategic tool for sustaining analytical reliability in an evolving pharmaceutical landscape. In addition, live trending of the control samples allows for a quick understanding of changes in method variability. Moreover, when these trends are viewed as an overlay on process data, we can quickly focus CPV OOT investigations on either the process or the analytics. Ferring BTG has adopted this CAMV strategy to strengthen the robustness of our analytical assays. By leveraging lifecycle principles, risk-based monitoring, and trending analytics, we can achieve enhanced method control and reduced variability, ensuring consistent product quality. Short Biography of Presenting Author Aviv Cohen, Ph.D. Senior Research Associate Aviv Cohen is an accomplished biochemist with extensive experience in pharmaceutical, food-tech, and medical device industries. Holding a Ph.D. in Biochemistry from Tel Aviv University, Aviv’s doctoral research explored cellular aging mechanisms using Saccharomyces cerevisiae as a model system. During this period, Aviv collaborated across laboratories, managed research operations, presented at international conferences, and earned awards for both research and teaching excellence. Currently serving as Senior Researcher and Data Analyst at BTG (Ferring), Aviv leads Continued Process Verification (CPV) and Continuous Analytical Method Verification (CAMV) initiatives, conducts process investigations, and applies advanced statistical analysis to support manufacturing operations. Aviv also manages local projects and global collaborations within Ferring. Previously, Aviv was R&D Manager at Better Juice, a pioneering food-tech startup, where Aviv directed a team of researchers for their innovative sugar-reduction technology. Earlier, at Luminera LTD, a pharmaceutical medical aesthetic company, Aviv was an R&D Researcher and Lab Manager and developed a patented medical device. Aviv has published multiple peer-reviewed articles on yeast aging and stress response and holds a European patent for advanced biomaterials.

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