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…
What Manufacturers Should Do Before the Scope of Annex 15 Expands to APIs The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has opened a public consultation on proposed revisions to Annex 15 (Qualification and Validation) of the PIC/S Good Manufacturing Practice (GMP) Guide. Highlighted by the Therapeutic Goods Administration (TGA) in March 2026, the Annex 15 consultation…
Why computerised systems, validation, and “state of the art” expectations now matter more than ever Medicinal gases are gases that fulfil the definition of a medicinal product and are regulated as such under PIC/S GMP Annex 6. They include products such as oxygen, medical air, nitrous oxide, nitrogen, carbon dioxide, gaseous mixtures and anaesthetics, when…
Analysing the implications of the draft Annex 22 for AI integration and digital transformation The pharmaceutical industry is on the brink of a digital revolution, and the draft GMP Annex 22 Artificial Intelligence signals a major shift in regulatory expectations for AI and digitalisation in GMP environments. We have previously reviewed the content of the…
MHRA Updates and Global Alignment for Product Recalls Defective medicinal products are under sharper regulatory scrutiny than ever. In early 2026, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated Guide to Defective Medicinal Products, signalling a refreshed emphasis on rapid defect detection, structured investigations, and decisive recall process. In Australia,…
Supporting resilience, performance, and wellbeing across therapeutic goods manufacturing Working in Good Manufacturing Practice (GMP) regulated environments has never been a low‑pressure endeavour. The responsibility to ensure patient safety, product quality, and regulatory compliance carries inherent stress, and this pressure has only intensified in recent years. As regulatory scrutiny increases, global supply chains remain fragile,…
Small Changes That Make a Big Impact in Therapeutic Goods Manufacturing Continuous improvement has long been embedded within Good Manufacturing Practice (GMP) frameworks, yet in practice it is sometimes misunderstood as a large-scale transformation exercise rather than a series of small, deliberate refinements. In therapeutic goods manufacturing environments, where change is carefully controlled and regulatory…
Exploring the behaviours, mindsets and practical habits of highly effective Quality leaders in GMP, and how they build cultures of trust, compliance and patient focus. Quality leadership in a GMP pharmaceutical environment requires far more than technical knowledge or familiarity with regulations. The best Quality leaders are those who can inspire confidence across the site,…
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