The ‘Periodic Manufacturer Update’ form, introduced in the TGA’s new GMP guidance , is designed to let drug firms notify the agency of changes in active pharmaceutical ingredient (API) and finished drug production.
The agency explained that the form, available on its website , will help sponsors “maintain evidence of GMP compliance of all overseas manufacturing sites used in the manufacture of registered or listed medicine.”
The GMP guidance, which also updates on the TGA’s implementation of the Pharmaceutical inspection co-operation scheme (PIC/S) for API and medicinal products, comes into effect on August 15.
Recall update
In a separate announcement released yesterday, the Australian drug regulator updated its guidance for drug makers in the event of a recall .
The update includes a list of co-ordinators as well as several new document templates that pharmaceutical producers should use to correctly initiate the withdrawal of an approved pharmaceutical product.