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

ByCarla

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…

World Environment Day and a Means to Find Sustainable Balance
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World Environment Day and a Means to Find Sustainable Balance

ByNic

When is World Environment Day held? World Environment Day is held each year on the 5th of June. This year, World Environment Day falls on a Monday (June 5, 2023). 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…

Independent Commissioning Agents

Independent Commissioning Agents

ByNic

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…

The Pharmaceutical Architect
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The Pharmaceutical Architect

ByNic

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 😉)….

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

ByPharmOut

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…