A Changes to an entry that involve consequential changes to pharmaceutical aspects of the product information B Changes to the specifications of the active pharmaceutical ingredient C Changes to the specifications of the drug product D Changes to the specifications of the excipients, raw materials and starting materials E Changes in synthetic route or manufacturing process for the active pharmaceutical ingredient F Changes to the method of manufacture of the drug product G Changes to the site of manufacture of the active pharmaceutical ingredient H Changes to the site of manufacture of the drug product I Changes to the source or manufacturing process of excipients of animal origin J Changes to the container/closure system or container components K Change to, or addition of, pack size L Changes to the shelf life or storage conditions of the drug product, or the retest period of the active pharmaceutical ingredient M Changes to labels N Changes to other aspects of quality data where the change does not create a separate and distinct good Depending on the nature of the proposed change(s), the following supporting technical data should be provided. If not provided, the TGA may request the data. Sponsors should be aware that the types of changes listed in this section are not exhaustive, and the technical data required represent the minimum data necessary for assessment. The TGA reserves the right to request data or information in addition to those specified below, if appropriate. The guidance provided below is in addition to the information in ‘How to apply to the TGA’, above. Comparative batch data Comparative batch data means a comparison of data between the pre-variation product and the proposed post-variation API or drug product.
A Changes to an entry that involve consequential changes to pharmaceutical aspects of the product information B Changes to the specifications of the active pharmaceutical ingredient C Changes to the specifications of the drug product D Changes to the specifications of the excipients, raw materials and starting materials E Changes in synthetic route or manufacturing process for the active pharmaceutical ingredient F Changes to the method of manufacture of the drug product G Changes to the site of manufacture of the active pharmaceutical ingredient H Changes to the site of manufacture of the drug product I Changes to the source or manufacturing process of excipients of animal origin J Changes to the container/closure system or container components K Change to, or addition of, pack size L Changes to the shelf life or storage conditions of the drug product, or the retest period of the active pharmaceutical ingredient M Changes to labels N Changes to other aspects of quality data where the change does not create a separate and distinct good Depending on the nature of the proposed change(s), the following supporting technical data should be provided. If not provided, the TGA may request the data. Sponsors should be aware that the types of changes listed in this section are not exhaustive, and the technical data required represent the minimum data necessary for assessment. The TGA reserves the right to request data or information in addition to those specified below, if appropriate. The guidance provided below is in addition to the information in ‘How to apply to the TGA’, above. Comparative batch data Comparative batch data means a comparison of data between the pre-variation product and the proposed post-variation API or drug product.
pm-minor-variations-chemical-130515.docx