A Game-Changer for Facility Design and Construction The announcement of the United States Food and Drug Administration (FDA) PreCheck Initiative in August 2025 marked a meaningful shift in how pharmaceutical manufacturing facilities can be planned, designed, and brought into operation in the US. Rather than waiting until construction is complete with a product application then…
Pharmaceutical warehouses are critical components of the pharmaceutical supply chain. A warehouse associated with a pharmaceutical manufacturing facility will typically be used for the storage of: Storage Condition Requirements for Pharmaceutical Warehouses Most of the pharmaceutical raw materials and finished products will have specified storage conditions requirements such as temperature, humidity, and light exposure. The…
When is World Environment Day held? In this blog, we will look into the significance of World Environment Day and how the pH scale can be used as a didactic means of critical thinking (i.e., as a means to help us understand at a high level what might be accomplished within facilities, in terms of…
Introduction The development of life sciences projects are invariably complex and time-consuming, this is where independent commission agents are needed. There are many moving parts, from process design and construction through to the installation and commissioning of various systems. It’s crucial to have a team that is dedicated to ensuring that all of the systems…
How does a Pharmaceutical Architect help your organisation? The role of a Pharmaceutical Architect is many things. But of all the things a Pharmaceutical Architect can provide for you and your GMP manufacturing facility, communication is arguably the most important. (Aside from making sure that your black pants match your black shirt and glasses 😉)….
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…
How the Built Environment Responds When Human Needs Change Unexpectedly (Human) needs unquestionably shape the built environment – meaning that buildings are designed and constructed to meet people’s fundamental needs. What if these needs change suddenly for some completely unexpected reasons – such as a pandemic outbreak endangering the whole world? How will (should?) built…
As a multidisciplinary Architectural & Engineering team, we get asked a lot of questions relating to the application of the National Construction Code (NCC) through the design phase of (pharmaceutical) facilities in Australia. A common question relates to the provision for escape. Pharmaceutical manufacturing facilities are generally considered to have a high fire hazard potential…
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