A practical playbook based on FDA’s March 2026 draft guidance FDA Form 483 observations remain one of the most consequential outputs of a US Food and Drug Administration (FDA) current good manufacturing practice (cGMP) inspection. While technically non-binding, the quality of a manufacturer’s 483 response often sets the tone for how the FDA classifies the…
Turning your Contamination Control Strategy (CCS) into a decision-support system By 2026, Annex 1 expectations have matured from “having a document” to “running a system”. The European Union (EU) Good Manufacturing Practice (GMP) Annex 1 revision formalised the requirement for a risk-based Contamination Control Strategy (CCS) and reinforced a prevention-led mindset for sterile manufacture. A…
Lessons from the March 2026 TRUE METRIX device correction In March 2026, the Therapeutic Goods Administration (TGA) published a market action for the TRUE METRIX® Blood Glucose Monitoring Systems, describing a product correction prompted by gaps in the clarity of the Instructions for Use (IFU). On the surface, the issue related to a single device…
What the TGA’s New Market Action Framework Means in Practice The Australian Therapeutic Goods Administration (TGA) fundamentally reshaped how sponsors manage recalls and other market actions when the Procedure for Recalls, Product Alerts and Product Corrections (PRAC) came into effect on 5 March 2025, and published a revision on 24 February 2026 . This change…
Why it matters now For a long time, menopause has sat quietly in the background of working life. It was experienced individually, managed privately, and rarely acknowledged in professional settings. That silence came at a cost – not only to the individuals affected, but to organisations that lost experience, capability, and leadership potential without ever…
A Quality Manager’s Perspective of AI Agency Risk Artificial intelligence (AI) is moving rapidly from passive assistance to active participation in regulated processes. Many organisations are comfortable deploying AI as a static tool; for example, to help draft documents, search standard operating procedures (SOPs), or summarise information. In these cases, existing quality and validation approaches…
What’s coming for PQS, documentation and validation The European Medicines Agency (EMA) has published its three‑year GMP work plan for the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group covering January 2026 to December 2028. While the document itself is not legislation, it provides one of the clearest forward‑looking signals of how EU Good…
Using regulatory transparency as a proactive planning tool for sponsors and manufacturers The Therapeutic Goods Administration (TGA) updated its GMP Clearance Sponsor Information Dashboard (SID) on 10 March 2026 as the regulator continues its efforts to reduce the GMP Clearance backlog. The SID now provides rolling views of processing timeframes, workload volumes and application quality…
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