Home › Forums › General Discussion › Ongoing/Annual stability studies in commercial pack › Reply To: Ongoing/Annual stability studies in commercial pack
Check with the regulatory authorities with a plan you propose. Go with data to show there is no influence on stability outcomes if you have “non-threatening” differences in outer packaging; For a conventional product, something like 3 months at 40C/75%RH for both scenarios could do it. Run it by your Quality and Regulatory Units in house before moving forward.
John O’Neill
