Cosmetic FDA Regulations (MoCRA)
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Cosmetic FDA Regulations (MoCRA)

New FDA regulations for cosmetic products: Updates to the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 USC 364 (FDA Cosmetic Regulations). MoCRA: FDA cosmetic manufacturing regulations MoCRA: Effective date for FDA Cosmetic Regulations Most of the provisions in MoCRA take effect at the close of 2023. These include mandatory facility…

The Pharmaceutical Architect
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The Pharmaceutical Architect

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 😉)….

Building Classification – Pharmaceutical Facility Design

Building Classification – Pharmaceutical Facility Design

What class of building is my facility? As architects and engineers, we get asked a lot of questions about pharmaceutical facility design. A common question relates to building classification – this is a critical initial step as it has a major effect on design, by determining the minimum technical requirements for the proposed building. What…

Carbon Neutral and Sustainable Operation Strategies in Pharmaceutical Manufacturing
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Carbon Neutral and Sustainable Operation Strategies in Pharmaceutical Manufacturing

We are proud to say that PharmOut is now a carbon neutral practice, in doing so reaffirming our commitment as a sustainable global consultancy practice. As a means of continuous improvement, this continues to prepare us for the challenges that face us in the responsible design and operation of buildings in working to reduce carbon…

Cross Contamination – Modern Engineering Solutions to the Challenge
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Cross Contamination – Modern Engineering Solutions to the Challenge

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…