To every thing there is a season, and a time to every purpose under heaven: A time to be born, and a time to die; a time to plant, and a time to pluck up that which is planted; A time to kill, and a time to heal; a time to break down, and a time to build up.
Ecclesiastes 3:1-3
Bet you never expected to see Ecclesiastes in a stability blog, yet it fits the ebb and flow of Life Cycle Stability; each phase is there for a purpose. There are times to build up more studies than you will need later. Once you see which formulations and packages prevail, you will be killing off the less successful combinations.
There will be times when studies break down with “Out of” results (Out of Expectation, Trend or Specification) and times when they are healed (finding an OOS to be an analyst error).
Life cycles bring change of suppliers, manufacturing sites, formulation, packaging, test methods, guidance, and a host of other developments. When it comes to stability, that’s life. Our challenge is to anticipate, detect, evaluate, and control their impact through wise use of stability studies.
Are we continually assessing our APIs and products? It wouldn’t hurt to develop our own list of stability seasons to make sure that shelf life doesn’t pass us by.
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