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  • FMEA: A Risk-Based Approach to Sterility Assurance
    or impending failure. A detection rating was assigned based on Table 1 criteria. After this process, the Risk Priority Number for each FMEA line item was calculated and ranked by RPN. The first level of analysis was to create a dot plot of the RPN values from the table. The RPN numbers are mainly
  • FMEA: A Risk-Based Approach to Sterility Assurance
    method of improving sterility assurance using a risk-based approach. This initiative focused on the use of Failure Mode and Effects Analysis (FMEA) to identify potential weak points in the sterility management process. The manufacturing facility described here is still early in its life cycle. Thus
  • Process Excellence in the Manufacturing Value Chain
    aims, systematically, to eliminate variation by Defining, Measuring, Analyzing, Implementing and Controlling processes, abbreviated as DMAIC. Within Six Sigma projects, a variety of tools are employed. These include: Failure Mode and Effects Analysis (FMEA) - a systematic group of activities
  • Precsion Metal Stamping Quality -- Acronyms You've Got to Know.
    As an engineer or designer, you expect precision metal stamping manufacturers to provide uncompromised quality. Zero defects is no longer a goal; it is a mandate. What are some of the processes and tools precision metal stamping companies use to ensure quality control?. SPC is just the beginning
  • QbD Takes Biopharma by Storm
    By Angelo De Palma, Ph.D., Contributing Editor FMEA is utilized at the lowest level, not only by top-down designers off site by process engineers on the plant floor. One of the first steps of FMEA is defining and detailing a process map: What steps in the process or formulation lead to the finished
  • Lean Pharma: If Only It Were This Easy
    had been rated as less important. In addition, this year, more respondents noted that they were using process analytical technologies (PAT) and that their companies were adopting Quality by Design. FMEA is also becoming more widely used, responses suggest. Howeverthere were some areas where goals
  • Embracing Risk
    By Bikash Chatterjee, President, Pharmatech Associates What is driving the confusion? I believe it is the concept of risk. As an industry we have built our quality thought processes on the notion of eliminating risk. Quality programs like supplier qualification, incoming inspection, documentation
  • From the Editor: Deconstructing Murphy
    ), whose roots are in the aerospace industry. The technique is designed to help determine all the possible ways a process or product can fail, rank these risks and ensure that development and design minimize the likelihood of failure. FDA included sections on FMEA in its 2006 guidance on Quality Systems
  • Combination Products: Navigating Two FDA Quality Systems
    By Steven Richter, Ph.D., Microtest Laboratories, Inc. The combo product manufacturer s largest challenge will be during the scale-up process, because additional quality control (QC) measures are required to determine the process scale-up parameter shift. During scale-up, combination products

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