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regulatory guidance

10 December 2019

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
  • ...
10 December 2019

A reference sample is a sample for the purpose of future analysis, which could refer to starting materials, packaging materials or finished products.

A retention sample is a sample representing the batch of finished product as distributed.

Samples from a stability trial program...

10 December 2019

For qualification and validation guidance, TGA encourage the use of PIC/S recommendation publications such as:

  • PI-006-3 Validation Master Plan, Installation and Operational Qualification, Non-
  • ...
10 December 2019

The Australian clinical trial handbook contains guidance on manufacturing products for clinical trials.

10 December 2019

Annex 11 has been updated to provide clarification of existing requirements to ensure that computerised systems are managed appropriately, particularly in relation to data management and integrity.

10 December 2019

Reduced sampling of starting materials

It is improbable that reduced sampling and...

10 December 2019

The Annexes to the code of GMP apply to Parts I and II, i.e. to the manufacture of cannabis as an active pharmaceutical ingredient as well as to the manufacture of the finished medicinal cannabis...

10 December 2019

Counterfeit products

Clauses 8.7 and 8.8 of the PIC/S Guide to GMP require that the procedures on complaints handling should include an assessment for counterfeit products. If counterfeiting is detected the TGA must be notified in accordance with the...

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