National Commission of Audit and the TGA

The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, …

Anlit Achieves TGA GMP Certification

PharmOut is pleased to congratulate Anlit for achieving GMP Certification from the Therapeutic Goods Administration in Australia.

Anlit is an innovative developer and producer of quality consumer vitamins, minerals and dietary supplements for children. Since …

New 2016 GMP Quiz

A New Year a New GMP quiz!

You’ve probably already done the old quiz, so test your updated GMP knowledge with the latest PharmOut 2016 GMP quiz.

All new questions have been developed as well and a …

TGA signs agreement for eCTD submissions

The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).

Plan Do Check Act - CAPA

Maintaining Control of your CAPA system

Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.