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Manufacture of medicinal cannabis for supply under 'approved access' provisions
Guidance on GMP compliance
The Manufacturing Principles require all medicines to be manufactured in compliance with the manufacturing standard (the Code of GMP) unless exempted in Schedule 7 or 8 of the Therapeutic Goods Regulations 1990.
Even where manufacture of medicinal cannabis products is not covered by a licence to manufacture therapeutic goods, GMP compliance is still required unless one of these exemptions applies.
The manufacturing standard that is applicable to the manufacture of medicines is the PIC/S Guide to Good Manufacturing Practice for medicinal products (the PIC/S Guide to GMP). This standard is mandatory for the manufacture of all medicines supplied in Australia, unless exempted under the provisions of the Therapeutic Goods Act.
The PIC/S Guide to GMP applies to the active pharmaceutical ingredient (API) as well as the finished medicinal product.
Questions and answers on GMP
Please refer to the TGA interpretation and expectations for demonstrating compliance with PIC/S PE009-13 on the TGA website for some further information on the interpretation of certain areas of the PICS guide to GMP.
Finished medicinal cannabis product
The finished medicinal cannabis product is the dosage form in which the medicinal cannabis is intended to be administered to the patient, for example as an oil, tincture, extract, capsule, tablet etc.
The manufacture of the finished medicinal cannabis product is required to be in compliance with Part I of the PIC/S Guide to GMP, as well as the relevant parts of the Annexes to the PIC/S Guide to GMP.
Active pharmaceutical ingredient (API)
The API is the active ingredient that is the starting material for the manufacturing process of the finished product. For medicinal cannabis, the API could be:
- an extracted and purified active component of the cannabis plant (for example a cannabinoid)
- an extract of specified parts of the cannabis plant
- powdered specified parts of the cannabis plant.
The term 'API starting material' refers to the starting material from which the API is made.
If your medicinal cannabis product is being used as an API in clinical trials, compliance with chapter 19 of Part II of the PIC/S Guide to GMP is of particular importance.
GMP does not apply to the cultivation and harvesting of cannabis plants for medicinal use. The introduction chapter of Part II of the PIC/S Guide to GMP (in particular in its page 3 Table 1) provides guidance on the process steps from where GMP is expected to be increasingly applied, depending on the API manufacturing process. The relevant entries of that table are copied in the table below:
|Type of manufacturing||Application of Part II of the PIC/S Guide to GMP to this type of product|
|API extracted from plant||Collection of plants||Cutting and initial extraction(s)||*Introduction of the API starting material into the process||*Isolation and purification||*Physical processing and packaging|
|Herbal extracts used as API||Collection of plants||Cutting and initial extraction(s)||*Further extraction||*Physical processing and packaging|
|API consisting of powdered herbs||Collection of plants and/or cultivation and harvesting||Cutting and commuting||*Physical processing and packaging|
The shading/asterisk indicates manufacturing steps to which the PIC/S Guide to GMP applies, which means:
- for extracted cannabinoids: GMP does not apply up to cutting and initial extraction but increasingly applies from the introduction of the API starting material into the process onwards
- for herbal cannabis extracts: GMP does not apply up to cutting and initial extraction but increasingly applies from further extraction onwards
- for powdered cannabis plant parts: GMP does not apply up to cutting and commuting but increasingly applies from the moment of physical processing and packaging of the powder onwards.
You may need to seek advice from a GMP consultant or seek legal advice if you are uncertain as to where GMP is required for your manufacturing process.
Annexes to the PIC/S Guide to GMP
The Annexes to the PIC/S Guide to GMP apply to Parts I and II, i.e. to the manufacture of the active cannabis ingredient as well as to the manufacture of the finished medicinal cannabis product.
All GMP Annexes that are relevant to your manufacturing processes apply. This may depend on the dosage form manufactured, or on specific process characteristics.
GMP Annexes that are relevant to the manufacture of all non-sterile medicinal cannabis products are:
- Annex 7 - Manufacture of herbal medicinal products
- Annex 8 - Sampling of starting and packaging materials
- Annex 15 - Qualification and validation
- Annex 19 - Reference and retention samples
- Annex 20 - Quality risk management.
Annex 20 is not mandatory; it is a tool to assist you in satisfying the mandatory quality risk management clauses 1.12 and 1.13 in Part I of the PIC/S Guide to GMP, and clauses 2.20 and 2.21 of the PIC/S Guide to GMP.
GMP Annexes that may be relevant to the manufacture of medicinal cannabis products depending on dosage form and process characteristics are:
- Annex 9 - Manufacture of liquids, creams and ointments: only relevant for medicinal cannabis products in these dosage forms
- Annex 11 - Computerised systems: only relevant for manufacturing processes where computerised systems are used
- Annex 13 - Manufacture of investigational medicinal products: it is relevant for medicinal cannabis products for use in clinical trials.