You are here

GMP clearance guidance

Version 18.1, January 2019

4 January 2019

Book pagination

Step 5 - Selecting your scope

Selecting the correct scope of your application is one of the key steps in submitting GMP clearance applications. Incorrect selections here may lead to issues with your product registration or listing activities.

Information on dosage forms and manufacturing steps is available in the TGA code tables (TGA Business Services → Public TGA Information → Code Tables).

Ensure you have read the relevant information contained within this guidance regarding what steps of manufacture require GMP clearance.
If you are unsure whether manufacturing step requires GMP clearance or aligns with the registration or listing requirements, please contact the relevant product regulatory area prior to submitting the application.

Ensure the dosage forms and manufacturing steps you select are supported by the evidence to be provided with the application and align with the details related to the product registration or listing.

If the selections you made result in validation issues with the regulatory submission system, you may be required to submit a variation application and pay the relevant fees.

Completing API/Product Details tab

In the API/Product Details tab, whether you select 'API' or 'Product' will determine the required information to be entered. Once chosen, you will then need to enter the name of the specific substance or dosage forms along with the required steps of manufacture performed at the manufacturing site.

You will need to submit separate applications for API and finished product, even if the same evidence is applicable to both.

  1. Select if the application scope is for 'API' or 'Product' by selecting the radio button.

    Screenshot - API/Product Details - Description: Underneath six lines of text are two radio buttons: 'API' and 'Product'

API scope

  1. If the application is for API, select 'API' and then select the type of APIs you intend to obtain GMP clearance for.
    • Select 'Sterile/Biotech' if all the APIs in your application are sterile or biotech substances
    • Select 'Non-Sterile' if all the APIs in your application are non-sterile substances
    • Select 'Sterile/Biotech & Non-Sterile' if the APIs in your application are a combination of both types of substances

    Screenshot - API radio button - Description: If you select API thenyou need to choose from three radio buttons to the right

  2. Select 'Add'.

    Screenshot - API window - Description: The Add button is in the bottom right corner

  3. You cannot enter the ingredient name directly. Instead, select 'Search' to open a search box of the ingredients database.

    Screenshot - API window - Description: You need to use the Search button right next to 'API Name'

  4. Enter the name or partial name of the ingredient in the Ingredient Search Dialog box and select 'Search'.

    Screenshot - Ingredient Search Dialog - Description: The search box is a free text field

  5. If the ingredient name is already registered with the TGA it will appear in the list for selection. Click on the required ingredient and select 'OK'.

    Screenshot - Number of entries found - Description: The number of entries found is displayed, followed by a scrollable list of all the entries

    If the required APIs are already registered with the TGA, proceed to instruction 26.

    If any of the API names are not already registered with the TGA and your search returns zero results, information about how to register an ingredient name will be displayed and you will have to manually enter the name of the API to proceed with the GMP Clearance application (instruction 25).

    For cell bank manufacturing activities, the name of specific cell lines are not required to be entered in your application and the API name may be entered manually as "cell bank".

  6. Enter the name of the API in the field labelled 'Enter New Ingredient Name' and select 'OK'.

    Screenshot - Enter Ingredient Name - Description: The 'Enter New Ingredient Name' field is available if there were no results found for your search

  7. Select the appropriate 'Manufacturing Step' from the drop down menu and click save entry.

    Screenshot - API - Description: A long scrollable alphabetical list is available for you to choose your manufacturing step. The display only shows four of these at a time, so it is a good idea to have looked up the step name in the Code Tables beforehand.

    To see the entire list of possible manufacturing steps, go to the 'Manufacturing Steps' code table (TGA Business Services → Public TGA Information → Code Tables).

  8. Repeat instructions 20-26 as required to add additional APIs and/or manufacturing steps.

Finished Product Scope

  1. If the application is for finished product, select 'Product' and then select 'Add'.

    Screenshot - Product Details - Description: The Add button is at the bottom on the right.

  2. In the dialog box, make the required selections from the drop down menu for the following manufacturing items:
    • Manufacturing Type - Generally the selection here would be Medicine Manufacturer or Testing Laboratory
    • Sterility - Select the sterility of the product
    • Manufacturing Class - Select either multiple or single manufacturing steps or products
    • Dosage Form - Ensure when selecting group terms, all the dosage forms contained within the group are supported by the evidence you submit. To see the entire list of possible dosage forms, go to the 'Dosage Form Group' Code Tables).
    • Product Code - Generally the selection here would be Listed or Registered Therapeutic Good
    • Manufacturing step - Ensure when selecting group terms, all steps of manufacture contained within the group are supported by the evidence you submit. To see the entire list of possible manufacturing steps, go to the 'Manufacturing Steps' code table Code Tables).
  3. Once you have chosen from every drop down menu select 'Save Item'.

    Screenshot - Manufacturing Items - Description: There are six drop down menus to choose from. The Save item button is at the bottom, slightly to the right.

  4. Repeat instructions 27-30 to add additional dosage forms or manufacturing steps.

Book pagination