Exploring practical, respectful ways for teams to collaborate, reduce friction, and build a proactive GMP culture Working in Quality Assurance (QA) can be professionally and emotionally demanding. Much of the role involves raising process deviations, challenging entrenched habits, and enforcing regulatory requirements in which colleagues may not immediately see the value. Over time, this can…
Capabilities, technologies, and global dynamics shaping Quality in GMP manufacturing As 2026 gets underway, Quality professionals in GMP therapeutic goods manufacturing are facing a mix of familiar pressures and promising opportunities. Digital tools are maturing, sustainability expectations are sharpening, and regulators are steadily aligning guidance across markets. Rather than treating these as discrete initiatives, teams…
Cleaning validation is a critical component of Good Manufacturing Practice (GMP), ensuring that residues from previous products, cleaning agents, and contaminants do not compromise product quality or patient safety. In multi-product facilities, the stakes are even higher. Traditional approaches often rely on fixed limits and exhaustive testing, but regulators and industry leaders are now advocating…
The Impact of Particulate Matter in Injections The impact of particulate matter in injections on clinical outcomes is influenced by several factors, including the size, shape, colour, and quantity of particles, the potential for microbiological contamination, the composition of the material, the target patient population, and the specific clinical condition of the patient. To minimise…
Pharmaceutical Manufacture in the New Era of AI Do you remember where you were when… the Berlin Wall fell? … Southeast Asia was struck by the tsunami? …a pandemic was declared for COVID-19? And what about when ChatGPT was released to the public? Whilst not as dramatic as the above events, in the short time…
A number of additions and updates were recently published for EudraLex Volume 4 – Good Manufacturing Practice Guidelines for stakeholder consultation, including Revision of Chapter 4 Documentation and: As a technical writer, this Chapter 4 change is one close to my heart, documentation being the backbone of all GMP activities. Who hasn’t heard that old…
You have survived the TGA inspection and are now waiting for the arrival of the dreaded Post Inspection Letter (PIL). Post inspection Letter Following a GMP inspection, the TGA will issue a manufacturer with a PIL. The PIL records any deficiencies identified during the inspection and categorises them as Critical, Major or Other. The deficiencies…
Introduction For anyone involved in the manufacturing of sterile medicinal products, the recent PIC/S GMP version 17 Annex 1 guidelines are nothing short of a bible. They delineate the rigorous standards necessary to maintain product sterility. One such crucial aspect outlined in these guidelines is cleanroom monitoring. In this blog, we aim to elucidate the…
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