Many European pharmaceutical companies seek to enter the Russian market, but have little to no experience with the Russian authorities and their inspectors. Please read more here
The new "Guidance on interpretation and implementation" of the ECA Foundation and Pharmaceutical Quality Group of the Chartered Quality Institute. Please read more here
This article focuses on maintaining the calibration and qualification of chromatographs to ensure data integrity of results during the Covid-19 pandemic. Please read more here
Marketing authorisation holders, manufacturers and clients must qualify their suppliers and contractors. An important part of such a qualification process is the performance of audits. Please read more here
The secong part of this series on the changes in GMP regulations happening during the past year covers the EU-US MRA, Annex 1, ICH Q12 and more. Please read more here
In the life science industry, surfaces pose different risks for the process depending on whether and how long they are in contact with the medicinal product. Please read more here
