The continued availability of medicines is one of the most important priorities for EU authorities during the COVID-19 pandemic. As such the The European Medicines Agency has provided guidance on Addressing Supply Chain Shortages Due to the COVID-19 Pandemic.... Read more
The impact of the Covid-19 pandemic on GxP supply chains and the lockdown measures mandated by the UK government and devolved bodies have resulted in restrictions in movement and the ability to visit supplier sites. This presents significant logistical difficulties in... Read more
On 4th March 2020, the transfer of the business and assets of the Tepnel Pharma Services brand of Hologic Ltd., to Tepnel Pharma Services Limited (Livingston, Scotland) was completed, creating a privately owned Quality Control (QC) laboratory. We are confident that... Read more
Stability studies are a time consuming and resource intensive task during the development of new drugs. Accelerated Stability Assessment Programme (ASAP) is an approach based on the Arrhenius equation whereby degradation increases with temperature and therefore using... Read more
Quality by Design (QbD) is a systematic approach to development that begins with setting a predefined objective and harnessing scientific understanding and risk based principles to establish a controlled process or in pharmaceutical drug development terms, product... Read more
The first of November 2017 has become a notable and unprecedented date in the history of medicines regulation. This is the first day of coming into force of a Mutual Recognition Agreement (MRA) of Good Manufacturing Practice (GMP) inspections of manufacturers of... Read more
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