Conclusion Report

The Conclusion report on stability study shall contain:

 

The Conclusion report on stability study shall contain:

  • – Identification of the lab conducting the testing
  •  – Identification of the product
  •  – Containing Primary packaging material used in the test
  •  – A description of the methodology used to determine the product’s minimum durability. If applicable, the specific preservation precautions should be mentioned.

  • – Study conditions (sample storage conditions, test time period and periodicity of the evaluations). In addition, the following should also be provided:
    • Evidence that the composition of the product used for stability testing corresponds to the product actually placed on the market;
    • The results of the preservative efficacy study, e.g., challenge test, if applicable;
    • When applicable, the period after opening (PAO) and its justification;
  • – The signature of the person responsible for the study

 

 

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