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Active pharmaceutical ingredient (API - Part II)

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
    • ...

Reference and retention samples (Annex 19)

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...

Qualification and validation (Annex 15)

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-
    • ...

Investigational medicinal products (Annex 13)

10 December 2019

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

On this page: Manufacture in...

Computerised systems (Annex 11)

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.

On this page: ...

Sampling of starting and packaging material (Annex 8)

10 December 2019

On this page: Reduced sampling of starting materials | Application of reduced sampling

Reduced sampling of starting materials

It is improbable that reduced sampling and...

Herbal medicinal products (Annex 7)

10 December 2019

On this page: Reference standards | Quantified by input | Good agricultural and collection practices (GACP) | Adulteration or substitution of herbal substances...

Annexes of the PIC/S Guide to GMP

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...

Complaints and product recall (Chapter 8, Part I - finished dosage form)

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...

Outsourced activities (Chapter 7, Part I - finished dosage form)

10 December 2019

On this page: Change in scope of chapter 7 | Managing outsourced activities | Legality of outsourced activities | Monitoring the contract acceptor |...

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