ISPE's CGMP Conference Continued with a Provocative Discussion on Process Validation
Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb moderated a night session on process validation. Dafni Bika, PhD, VP, Global Manufacturing and Supply, Bristol Myers Squibb, discussed the implementation status of the lifecycle validation paradigm. She asked delegates "What is process robustness?" "Robustness", she said, is a strategic initiative and a natural extension of Quality by Design (QbD)" She went on to clarify that when we talk about "in control" adding that what we mean is "in statistical control." Karthik Iyer, Senior Policy Analyst, CDER/OC/OMPQ, FDA, presented a regulatory update on the new paradigm in validation, including recently issued warning letters and 483 observations.
Following the informative and rather provoking discussion, a panel including Alex Vichmann, Operations Research Analyst, CDER/OPS/SRS, FDA; Rick Friedman, Associate Director, Office of Manufacturing and Product Quality, FDA/CDER/OMPQ; and Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly& Co. answered a variety of in-depth and thoughtful questions from the audience. Questions ranged from topics regarding data mining, raw material variability, process robustness, and the point at which you can stop manufacturing. The Q&A continued with process monitoring, testing differences between data flow of biologics, oral solid dosage forms, and the status of dialogue with other health authorities.
PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference couldn’t be better. The Equipment Innovation and Annex 1 Implementation Track Co-leads Richard Denk and Matthew Gorton and the Emerging Leader Co-lead Pol Bonet invite you to join them for this exciting event in...
The pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally. This unceasing drive for innovation and improvement has led the industry to embrace cutting-edge technologies like data analytics, machine learning, and artificial intelligence. These technologies are not just trends;...
With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents. With the co-leadership of Christian Wöelbeling, Executive Industry Advisor at Körber Pharma...