TGA launches ‘periodic update’ form for GMP compliance at overseas plants

- Last updated on GMT

Related tags: Pharmacology, Medicine

The Australian Therapeutic Goods Administration (TGA) has introduced a new mechanism to help drugmakers maintain evidence of GMP compliance at manufacturing facilities outside the country.

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.

Related topics: Markets & Regulations, Globalization, QA/QC

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