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Minor variations to prescription medicines, Appendix 2: Variation change types - biological medicines

Version 2.1, January 2018

23 January 2018

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Fermentation process changes

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Notifications

These variations fall under s. 9D(2C) of the Therapeutic Goods Act 1989.

Conditions that are outlined below the description of each variation type must be met for the request to be processed as a notification.

FPFM: Fermentation - change of filter manufacturer

Change to the manufacturer of the filter used in the fermentation process.

  • Do not change the internal process controls.
  • Do not use the filter for steps that require viral safety validation.
  • The new filter meets the same acceptance criteria as the previous filter.
  • The new internal process controls for the filtrate have not been changed.

You must submit:

  • The reason for the change.
  • The new manufacturer's details.

FPNC: Fermentation - more stringent internal process controls

Introduction of more stringent internal controls on the fermentation process.

  • Do not change the quality characteristics of the product.

You must submit:

  • The reason for the change.
  • Details of the new internal process controls.

FPRP: Fermentation - reduction in fermentation period

Reduction in the fermentation period, i.e. the time required to culture and harvest the cell line.

  • Reducing the fermentation period must not change the batch size.
  • Do not change the internal process controls.

You must submit:

  • The reason for the change.
  • Details of the change.

Other fermentation process changes

Other fermentation process changes require the TGA to evaluate data. See:

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