by Alexander Perez | Apr 16, 2020 | Uncategorized
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 by Alexander Perez | Mar 6, 2020 | Uncategorized
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 by Alexander Perez | Feb 5, 2019 | Uncategorized
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 by Alexander Perez | Feb 5, 2019 | Uncategorized
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 by Alexander Perez | Feb 5, 2019 | Uncategorized
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