Suitable methods to maintain stability of the product in appropriate container closure systems should be also developed and tested.

Analytical methods to test those attributes that are susceptible to change  and are likely to influence quality, saftey and/or efficacy should be developed and eventually validated.

Prior to approval significant amounts of data must be made available in establishing re-test periods, shelf life, storage and in use conditions. A detailed study protocol should be finalised and conducted in consideration of relevant guidelines e.g. ICH.