ARTICLES BY BIKASH CHATTERJEE
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![Compliance-GettyImages-1427652539]( "Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program")
Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program7/7/2026In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.
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![Measuring Success GettyImages-1319232417]( "Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools")
Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools6/30/2026Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.
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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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![Monoclonal antibodies GettyImages-1341967287]( "Emerging Trends In mAbs Manufacturing In 2025 And Beyond")
Emerging Trends In mAbs Manufacturing In 2025 And Beyond2/11/2025Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics 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.