Manufacturing basics

Manufacturing therapeutic goods

  • Manufacture of therapeutic goods
    Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods.
  • Good manufacturing practice - an overview
    The term Good Manufacturing Practice is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality
  • Manufacturer statutory declarations
    Statutory declarations are required whenever certain situations or business operations change
  • Technical working groups
    Technical Working Groups have been established to bring together manufacturing technical expertise from industry and the regulator to address the grey areas or vagaries of the cGMP as it relates to manufacturing

Manufacturer inspections