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Active substance starting material(s) – importance of selection

  • 4 December 2014
  • active substance, API, cell banks, cell substrate, GMP, ICH Q11, Master Cell Bank, MCB, redefinition, starting material, WCB, Working Cell Bank,
According to the Part II: Basic Requirements for Active Substances used as Starting Materials of the EU GMP Guide, the manufacturer should designate and document the rationale for the point at which production of the active substance begins. For synthetic processes, production of the active substance begins at the point at which “Active Substance Starting
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