In recent years, the assessment of topical products has evolved. It has become evident that their quality needs to be thoroughly understood and characterised, supported by a robust manufacturing process and control strategy. In addition, the designated shelf life needs to be based not only on physical, chemical and microbiological stability, but also, when necessary, on evidence of stable in vitro performance to assure equivalence throughout storage.



Posted on the EMA website on 22 April 2015