Your Ongoing Audit Program — Internal, Mock Regulatory, and Supplier Audits

Your Ongoing Audit Program — Internal, Mock Regulatory, and Supplier Audits

Quality Systems Now
Published on: 04/11/2026

An effective audit program is a fundamental component of a functioning quality management system (QMS).

Your Audit Program
TGA Will Start Publishing GMP Inspection Outcomes

TGA Will Start Publishing GMP Inspection Outcomes

Quality Systems Now
Published on: 01/11/2026

The key change is that GMP inspection outcomes will become publicly visible, rather than remaining information communicated primarily between the TGA and the inspected manufacturer.

Public Inspection Outcomes
Getting a manufacturing site licensed or a laboratory accredited

Getting a manufacturing site licensed or a laboratory accredited

Quality Systems Now
Published on: 28/10/2026

Establishing a manufacturing site or laboratory is a significant undertaking for any organisation operating in the therapeutic goods, biotechnology or analytical testing sectors.

Site Licencing
How to Complete a GMP Supply Chain Risk Assessment

How to Complete a GMP Supply Chain Risk Assessment

Quality Systems Now
Published on: 26/10/2026

GMP supply chain risk assessment is not simply an exercise in assigning risk scores. It is a disciplined process for understanding the organisations and activities on which product quality depends.

Supply Chain Risk Assessment