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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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PIC/S Guide to GMP

The PIC/S Guide to GMP, as determined in the latest therapeutic goods (manufacturing principles) determination, is the mandatory standard for the manufacture of medicinal cannabis under provisions of section 36 in the Therapeutic Goods Act 1989.

Section 36(1) of the Therapeutic Goods Act 1989: The Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans.

The TGA uses internationally harmonised manufacturing standards, such as the PIC/S Guide to GMP to allow manufacturers to operate in an international environment.

The TGA adopted the 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

Periodic changes

GMP requirements change over time due to various reasons, such as to:

  • provide guidance for the management of new technologies
  • address gaps or clarify existing compliance requirements
  • manage risks identified through inspections and regulation
  • facilitate continuous improvements in the way medicines are manufactured

The TGA maintains its GMP standards in line with updates issued through PIC/S Guide to GMP. Regular updates are necessary to:

  • maintain mutual confidence with international regulators
  • promote quality assurance of inspections
  • promote harmonisation of technical standards and procedures with international inspection standards for the production and testing of medicinal products

Application of the PIC/S Guide to GMP

The sections of the PIC/S Guide to GMP that apply to medicinal cannabis will be determined by the nature of your operations and the variety of products or dosage forms you manufacture.

For example, manufacturers of finished dosage forms should in general follow the principles of Part I of the PIC/S Guide to GMP. This includes all annexes relevant to their operations and dosage forms such as:

  • Annex 7 (herbal products)
  • Annex 8 (sampling)
  • Annex 11 (computerised systems)
  • Annex 15 (qualification and validation)
  • Annex 19 (reference and retention samples)

Manufacturers of active pharmaceutical ingredients (APIs) should follow the principles of Part II of the Guide, including all annexes relevant to their operations, such as:

  • Annex 7 (herbal products)
  • Annex 19 (reference and retention samples)

Note that annexes 8, 11 and 15 do not directly apply to the manufacture of APIs for medicinal cannabis as specific guidance for APIs is provided within Part II of the guide; these annexes may be used as supplementary guidance without introducing additional requirements.

Guidance within annexes for specific dosage forms or product types should be read in conjunction with the relevant part of the Guide (Part I or II), e.g.:

  • a manufacturer of medicinal cannabis dosage form made from herbal material i.e. non sterile Schedule 8 registered product should meet the requirements of Part I and Annexes 7, 8, 9, 11, 15 and 19
  • a manufacturer of API herbal ingredient (medicinal cannabis API) and non sterile schedule 8 registered finished product should potentially meet both Part I & II with Annexes 7, 8, 11, 15 and 19

Book pagination