The FDA updated the Q&As concerning the conduct of clinical trials during the COVID-19 pandemic. The document provides general considerations to assist sponsors in assuring the safety of trial participants & maintaining GCP compliance. Amongst others the guidance deals with electronic signatures, remote monitoring and re-monitoring after pandemic-related restrictions are lifted.
The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.
Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So remote-FATs came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.
Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.
Medical use of cannabis has been legalized in Panama in October 2021. The new regulatory framework allows the use and controlled access to medical cannabis for therapeutic, medical, veterinary, scientific and research purposes.
The validation of computer-based systems is a regular part in GMP inspections. In this context, the IT infrastructure has also become an important topic. Read more about the regulatory requirements and deficiencies in inspection practice.
The dissolution test is a key test parameter routinely used for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. This article will give a short overview of the test's purpose and the apparatuses according to the European Pharmacopoeia.
On 13 August 2021, the Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar "Protecting the medicines supply chain from falsified medicines". A link to the recording and updated information addressing some key questions received during this webinar have now been published on the MHRA Inspectorate blog.
Chapter 2 of the EU GDP Guidelines requires a written training programme. But what exactly does this mean and how can it be put into practice?
During several ECA events, the question came up whether it is allowed to take personal medication into the storage area.