Hi,

What is the industry trend for finished goods retention samples? Given the Annex 13 requirements for a “retention sample” from each finished goods IMP batch, are companies still taking 1 retention sample from every production run of each kit type? Or. are others moving to store electronic records and component samples, as allowed by the Annex . e.g. store the electronic packaging records, plus samples of each drug product lot and component including a printed label sample?

Thank you,
Summer