The Next Regulatory Alignment Wave Global Good Manufacturing Practice (GMP) expectations are entering a new phase of GMP convergence. Regulatory across the Pharmaceutical Inspection Co‑operation Scheme (PIC/S) and the European Union (EU) have signalled a clear direction of travel: validation, data integrity, and computerised systems are no longer treated as parallel disciplines – they are…
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…
In the pharmaceutical and biotechnology industries, cleaning validation is a critical process to ensure that equipment used in manufacturing is free from contaminants that could affect product quality and patient safety. However, there are instances where toxicological data for certain residues may not be available. This blog explores strategies and best practices for conducting cleaning…
What were the changes? In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in…
New partnership offers cost-effective paperless validation to GMP – governed organisations in Australia. PharmOut, the Asia Pacific’s leading Pharmaceutical consulting organization, has announced a strategic partnership with ValGenesis Inc, a pioneer in paperless validation software systems. Pharmaceutical, medical device and other GMP-compliant industries incur considerable costs in creating, maintaining and storing the mountain of paper-based…
Virtual Qualification, how can Pharma 4.0® thinking help during Covid-19 lockdown and what lessons can we apply to virtual qualification? The events of Covid-19 have opened up a new world of vulnerability to all industries, and especially those highly regulated like the medicinal products manufacturers and the possibility of Pharma 4.0® Virtual Qualification as a…
Congratulations Colin Byrne PharmOut is delighted to announce that Colin Byrne has been promoted to the role of Senior Consultant. Colin has over 12 years of experience in the pharmaceutical industry, including more than 4 with PharmOut. He has gathered a wealth of experience in equipment qualification, process validation, and compliance, most notably in sterile…
On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, I will discuss the changes between the draft version and the revised Annex 15 version.
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