From Section A, stability studies S1 and S2 can be done for situations where "the shelf life of the characteristic is known and extends beyond the expected duration of the study".
I'm uncertain of the terms used. What constitutes a cycle? Is it time based?
Where is S1 (single part, single measurement per cycle) used compared with S2 (n >= 3 parts, single measurement per cycle per part).
I'm uncertain of the terms used. What constitutes a cycle? Is it time based?
Where is S1 (single part, single measurement per cycle) used compared with S2 (n >= 3 parts, single measurement per cycle per part).