GDP requirements (Updated Jan 2023)

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging?

No. According to the  Guideline on declaration of storage conditions (CPMP/QWP/609/96 Rev. 2) , marketing authorisation holders have to provide stability data for storage conditions at 25°C / 60% relative humidity (RH), or 30°C / 65% RH (long term) and 40°C / 75% RH (accelerated), in order to justify not including a statement in the medicinal product labelling.

This stability data is generated according to the temperature and humidity conditions of climate zone I (temperate) and II (Mediterranean/subtropical) in Europe. For more information, see the World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations forty-third report, Annex 2: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products.

No labelling statement means that controls should be in place to maintain conditions relevant to climate zones I and II. Consequently, the temperature should be monitored during storage and transport. Appropriate limits should be set for temperature monitoring to ensure that product stability is not adversely affected.

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