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Drugmakers' Guide to Quality API Manufacturing
November 11, 2015
There has been a steady increase in the requirements that govern active pharmaceutical ingredients (active substances) in the last few years, a trend that is expected to continue. The changes affect more than simply the classic quality area of active substance manufacturing. They extend to new requirements for importation (e.g., written confirmation for active substances exported to the EU) and regulatory submissions (e.g., QP declaration). In addition, Europe requires registration of manufacturers, importers and wholesale distributors of active substances. And drugmakers must assess even the raw materials used to manufacture active pharmaceutical ingredients for possible impacts on product quality.