GMP NEWS 2021

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.

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.

Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

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.

During several ECA events, the question came up whether it is allowed to take personal medication into the storage area.

In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

The US FDA reports deficiencies during inspections in the so-called Form 483s. These reports are partly public, and the FDA subjects them to trending by key points. The evaluation of the last year 2020 shows a significant increase in inspection deficiencies with regard to equipment.

The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?

The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.