As a regulatory specialist, you often have to check that the storage instructions of medicinal products are compliant and correct. Suitable storage conditions, consistent with those defined in the SPC, should also be included in the package leaflet and on the product labelling.
The storage conditions for medicinal products should be based on an evaluation of the stability studies undertaken on the finished product. This is where collaboration with the pharmaceutical-chemical expert comes in handy: the conclusion of the stability section in a new marketing authorisation application should be written so that the storage conditions in the SPC can be taken directly from the conclusion.
Storage instructions on the label or the product package are based on study data and the product manufacturer’s special expertise. As a regulatory specialist assessing product information, make sure – with the help of your pharmaceutical chemical expert – that the instructions given to the product’s end-user are sufficiently supported by appropriate scientific data.
We have created a guide on what you need to know about determining storage conditions for pharmaceuticals, so that you can make the best choices for your project.
