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Complying with the manufacturing principles for medicines

Complying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).

The TGA has adopted version PE009-14 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for:

  • medicines and active pharmaceutical ingredients
  • biologicals that comprise or contain live animal cells, tissues or organs.

PE009-14 does not apply to:

  • medical devices
  • biologicals that comprise, contain or are derived from human cells or human tissues.

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