ARTICLES BY BIKASH CHATTERJEE
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![Business risk, disruption, crisis management, obstacle-GettyImages-2264477453]( "Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures")
Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures6/23/2026A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.
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![Pharm Manufacturing Facility GettyImages-1087218874]( "CMC And Quality Considerations When Engaging Your CDMO")
CMC And Quality Considerations When Engaging Your CDMO3/21/2022Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead.
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![GettyImages-1044232264-team-lab-collaboration-teamwork-planning]( "FDA's 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch")
FDA's 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch3/19/2021Examine key elements from the report “Advancing Regulatory Science at FDA: FARS” that provide meaningful regulatory insight on new and emerging approaches to drug development and governance.
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![Robotics]( "FDA Steps Up Support For Advanced Manufacturing Technologies")
FDA Steps Up Support For Advanced Manufacturing Technologies2/22/2021Examine the potential of the FDA and NIST's MOU to provide critical technical guidance that could greatly standardize the approaches to implementing AMTs, such as those used in continuous manufacturing.
Bikash Chatterjee
Bikash Chatterjee is president and CSO of Pharmatech Associates, a USP Company and USP Microbiology. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products. His work has guided the successful approval and commercialization of over a dozen new products in the U.S. and Europe. Chatterjee is a member of the USP National Advisory Board and is the past chairman of the Golden Gate Chapter of the American Society of Quality. He is the author of Applying Lean Six Sigma in the Pharmaceutical Industry and is a keynote speaker at international conferences. Chatterjee holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.