The area of responsibility of the Responsible Person for Good Distribution Practice is quite extensive. Therefore, the question arises which tasks actually have to be performed personally and which duties can be delegated.
On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?
Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the total thickness for a blister foil?
Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.
A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.
The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?
The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.
The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.
The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.
Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.