Blog
November 27, 2023 || Geraldine Carr-Mulry
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This paper, updated in January 2022, serves as an important guideline for MAH to understand their GMP responsibilities, especially in cases where they may not be…
November 27, 2023 || Jonathon Thompson, Director - Product Management
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 validation, quality, or compliance function in industries governed by Data Integrity or ICH, FDA, and EU GMP Guidelines. This year’s survey results concluded that the…
November 21, 2023 || LeAnna Pearson
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. Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S. Their…
November 20, 2023 || Rosario Hughes-Kielty
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 Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…
November 10, 2023 || Connie Leech
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. The newest regulation that biotech companies, operating in the European Union (EU) must now contend with is Annex 1 of the EU Good Manufacturing Practice…
November 10, 2023 || Nick Armstrong
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, and supply chain optimization. However, as we unlock the potential of AI, we acknowledge and tackle concerns like data quality, fairness, and regulatory compliance for responsible implementation. Join us in revolutionizing drug manufacturing and ensuring reliable access to essential medications through the transformative power of AI.
November 10, 2023 || Connie Leech and Geraldine Carr-Mulry
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, drug shortages have persisted on a global scale. The demand for flexibility in the supply chain remains imperative, However, many drug manufacturers are still reluctant…
November 3, 2023 || Tom O'Farrell, Director of Client Engagement, Europe - Data Centre Services
“The bee is more honoured than other animals, not because she labours, but because she labours for others.” – St. John Chrysostom There appears to be constant negative attention towards Data Centres from the media in Ireland. Since the benefits of Data Centres are not reported fairly, then It shouldn’t…
October 13, 2023 || Trent Vaden
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. Early engagement is a key component to overcoming the challenges to successful data center startup, due to the complexity and critical nature of the systems…
September 29, 2023 || Robert Ossig
Protein Folding BackgroundIn the realm of drug development, the intricacies of protein folding have long posed a significant challenge. The way a protein folds directly impacts its function, and any misfolding can lead to diseases like Alzheimer’s, Parkinson’s, and cystic fibrosis. Additionally, the field of Advanced Therapy Medicinal Products (ATMPs)…
