The GMP/GDP Inspectors Working Group has put up and approved a list of frequently asked questions (FAQs) on Good manufacturing practice (GMP) and Good distribution practice (GDP) that the European Medicines Agency (EMA) posts on its website.
The list was revised on January 2023. There were three more GDP-related questions added.
Maintaining an eye on storage conditions
The initial inquiry is as follows:
Is it appropriate that pharmaceutical products without any predefined storage parameters on the outer package have their storage conditions not monitored?
The response to the query is a resounding “No.” Holders of marketing authorizations must offer stability data to back up their decision not to include a statement on the label of a medical product. These stability statistics are produced in accordance with climate zones I and II. No labeling statement, according to the EMA, specifies that measures should be in place to keep conditions appropriate for climate zones I and II.
Activities of Brokers
The last two inquiries concern the interactions between brokers and persons outside the EEA:
Is it permissible for a broker to facilitate transactions between parties outside the EEA?
Can a broker engage in broker operations for pharmaceuticals without an EEA marketing authorization (but with an EEA marketing authorization in country outside EEA)?
These two queries likewise receive a resounding “No” in response to the demands of the EU GDP Guidelines.