This technical alert is an update for industry on the following matters in relation to COVID19 developments:
- Current TGA approach to domestic GMP inspections
- Advice in relation to extending GMP clearances
- Changes to hand sanitiser regulation - a new "excluded goods" category which declares that specified products are not therapeutic goods. This is to facilitate the manufacture and supply of large quanitties of hand sanitisers during the current pandemic's high demand. These new "excluded goods" hand sanitisers must comply with specified formulation, manufacturing, labelling, and advertising requirements. These requirements (including amended requirements). More here.