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 future of pharma & medical device manufacturing is already here, and what’s not here yet is rapidly unfolding. There’s a lot to take in this year in terms of industry trends, new technologies, and GxP & GMP compliance guidelines for pharmaceutical and medical device organisations! It would be nice if the latest AI technologies…
What is a clean room? A cleanroom (GMP cleanroom), in my mind, is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. This blog will attempt to explain the necessary characteristics of a regulated company clean room not producing potent…
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…
Hydrogen Peroxide Vapour (HPV) or Vapour-phase Hydrogen Peroxide Systems (VHP) as it’s more commonly known, has been used for many years as a contactless method of decontaminating cleanrooms and hospitals. It has also seen use most recently in indoor public spaces of known virus or bacteria contaminated sites such as the recent outbreaks of Covid-19…
The first references to the term “dedicated facility” appeared in GMP literature in the early 2010s in response to potential cross contamination risks of manufacturing toxicologically sensitive products in shared facilities. The WHO Technical Report Series, No. 957, 2010 ‘Annex 3 WHO good manufacturing practices for pharmaceutical products containing hazardous substances’ specifies that “production of…
Well-designed cannabis production workflows can help business owners understand the benefits of efficient and secure operating procedures in Medicinal Cannabis cultivation and production/manufacturing. When it comes to the production of pharmaceutical-grade cannabis products and extractions (medicinal marijuana products), errors are extremely costly. A mistake can lead to crop damage, excess waste, higher cultivation and production…
Clean room turn down is a growing discussion in the Pharma industry and is usually reflected in corporate policy; if you google ‘sustainability’ and a top ten pharma company name, you’ll find taglines like GSK’s “Our Planet – Our Responsibility”. Sixty-five of the top 100 listed companies in Australia are reporting their sustainability credentials in…
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