Quality by Design White Papers & Case Studies
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Multivariate Data Analysis For Biotech and Bioprocessing
The modern biopharmaceutical/biotechnology manufacturing facility contains many sophisticated control, data logging, and data archiving systems. Massive amounts of data are collected from sources such as raw materials analysis, process outputs, and final quality assessments, which are stored in data warehouses.
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Flexibility In Sterility Testing And Managing Risks Of False Positives
This paper reviews the background to false positives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation. By James Drinkwater, Bioquell UK Process & Compliance Director
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A Strategy For Implementing Rapid Microbial Methods
The purpose of this white paper is to present a strategy to be used and applied for rapid microbiological methods (RMM). By Gilberto Dalmaso, Sterility Assurance Consulting, A&L Co
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Biological Contamination Management In Aseptic Environments: Requirements And Expectations
Bio-contamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources. By James Drinkwater
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Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. By Dr. D. Dixon, University of Ulster
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QbD’s Role in Pharmaceutical Solid Dose Dry Granulation
The Pharmaceutical industry is undergoing change. Under fire by political pressures to drive down the cost per tablet, compounded by new drug discovery becoming more challenging escalating research costs, therefore, the industry is looking to unleash its efficiency shackles of the past.
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A QbD Approach To Freeze Drying Of Cytotoxic Compounds
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward