Every stability study has one (unless maybe you are a stability study featured in a Warning Letter). A protocol captures the design of a stability study, but should it be more than Conditions, Intervals and Tests? The guidances steer us in that direction, decreeing that “The primary stability program should be described in a written protocol” and “The design of the stability studies for the Finished Pharmaceutical Product should be based on knowledge of the behavior and properties of the API, information from stability studies on the API and on experience gained from preformulation studies, clinical formulation studies, and similar marketed formulations. The likely changes on storage and the rationale for the selection of attributes to be tested in the formal stability studies should be stated.” In building a stability protocol, it would serve us well to think in terms of these components of design. They provide a platform of Justifications for each aspect.

When searching for a document that best describes the design of your stability study, what better place to go than a well-constructed protocol; built on science, compliance, statistics, timing and nature of registration and justification?

On the other hand, if we fail to build a solid protocol and not manage change control, we risk:

  • Disconnects to the “story” of our product
  • Ambiguity of process and container-closure details
  • Limited scope of design, omitting special international requirements
  • Missing input from supporting key disciplines
  • Missing revisions and changes in aspects such as Test Methods and Specifications
  • Late additions of Contract Research Organizations may not be noted and tracked.
  • Receiving a regulatory citation or Warning Letter that announces our protocol failures to the world

As stabilitarians, what elements of quality can we add to our own corporate stability protocols? Chime in (with a free account) at our discussion board!

John O’Neill
Editor, StabilityHub