Case Histories

Case Histories

Case Study: Tablet reformulation Technology Transfer / Scale-up

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: TABLET Needs: Modify tablet formulation and meet several reference features Modify manufacturing processes Reduce costs Increase market competitiveness Actions: Quality Risk Management including Process Mapping Design of Experiment Situation To reduce costs and increase market competitiveness, a global pharmaceutical company decided to modify the formulation and some manufacturing process stages for a drug in tablet administration form. Some main objectives were to meet the reference…

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Case Study: Dry Powder Inhaler Scale-up

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: MULTIDOSE DRY POWDER INHALER Needs: Scale-up the productivity of the molding and assembly manufacturing processes Scale-up the productivity of the drug product formulation process Keep Quality Costs within budget Complete the project in a timely and cost effective manner Actions: Project Risk Management Design for Manufacturing Project and Quality Risk Management Design of Experiment Situation A leading global pharmaceutical company wanted to scale-up the moulding,…

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Case Study: Integrated Quality Risk Management

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: COMBINATION PRODUCT Needs: Integrate Quality Risk Management and Quality System Management (R&D and Manufacturing) Increase company’s process/product knowledge Reduce project cost, time, and resource investment and future investment Actions: Business Risk Assessment & Planning Guideline Implementation Phase SOP Implementation Phase & Continuous Improvement Situation In the last few years, regulatory authorities set a new and even higher bar of mandatory quality for pharmaceutical companies. Part…

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Case Study: Knowledge Acceleration

CLIENT: GLOBAL PHARMACEUTICAL COMPANY PRODUCT: DEVELOPMENT OF NEW ASSEMBLY PROCESS FOR A NEW DRUG DELIVERY SYSTEM Needs: Transfer the existing technology to a new CMO Develop a second generation of the process in order to increase the manufacturing volume and increase the product quality Actions: Process mapping and modeling Process knowledge generation and deployment Situation A global pharmaceutical company needed to transfer a semi-automated production line for a new drug…

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