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

• Manufacturer inspections - an overview
  Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with manufacturing principles
• Manufacturer inspection - typical example
  Activities associated with a typical inspection include activities: before the inspection; at the inspection; after the inspection
• Manufacturer inspections - a risk-based approach to frequency
  The TGA employs a risk-based approach to the frequency of manufacturer inspections.
• Manufacturer inspections - product/process risk classifications
  The emphasis and depth of manufacturer inspections, as well as the frequency of inspections are guided by the inherent risks of the product and the method of manufacture
• Guidance on licensing/certification inspections
  The TGA performs inspections of Australian manufacturers of therapeutic goods to ensure that they meet an acceptable standard of GMP or comply with QMS standards
• Manufacturer compliance history
  A manufacturer's compliance history is used as part of the TGA inspection frequency matrices to help determine the frequency of manufacturer site inspections.
• Inspections and inspectors: the complaint process
  The TGA recognises that the effective management of complaints and disputes contributes to improvements in regulatory services