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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Munzinger Str. 9 Allzuoffensichtliches" soll von einer "Kultur"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC