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In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This...

CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey.  The survey targets current professionals in a...

Introduction PIC/S was founded in 1995 as an extension of PIC  (Pharmaceutical Inspection Convention).  They are a non-binding cooperative arrangement between 56 different Regulatory Authorities....

To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...

In the dynamic world of biotechnology, where innovation is moving at a rapid pace and patient safety is paramount, compliance with regulatory standards is non-negotiable....

Explore the positive impact of artificial intelligence (AI) on pharmaceutical manufacturing, addressing persistent drug shortages. Dive into the benefits of predictive analytics, quality control enhancements,...

COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away,...

"The bee is more honoured than other animals, not because she labours, but because she labours for others." - St. John Chrysostom There appears to...

As the data center market continues to grow exponentially, 3rd party testing and commissioning becomes vital to achieving Operational Readiness on time and in budget....