Manufacturing

• Manufacturing basics: medicines and biologicals

  Links to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.

• Manufacture of therapeutic goods

  Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods.

• Manufacturer inspections: an overview

  Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards.

• Make a statutory declaration

  Information on when statutory declarations are required by the Therapeutic Goods Administration (TGA).
  

• Declaration of intent to supply the Australian market

  This information is for Australian sponsors or agents of Australian sponsors of overseas manufacturers making GMP certification applications.

• Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence

  As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS.

• Data Management and Data Integrity (DMDI)

  Clarification regarding the TGA's position regarding DMDI practices for industry.

• Notices for manufacturers

  These notices are for manufacturers of medicines, biologicals and blood, blood components and HPCs.

Good manufacturing practice

• Good manufacturing practice: an overview

  Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.

• GMP clearance Sponsor Information Dashboard (SID)

  Information about current processing times, workload, priorities, and key messages for GMP Clearance applications.

• Good manufacturing practice (GMP)

  Information on complying with good manufacturing practice (GMP).

• How to obtain GMP clearance through inspection reliance

  Find out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.