7 Stability Trial Tips

7 Stability Trial Tips

Posted 28 April 2016

Performing stability trials can be a complicated and expensive exercise, especially as they are required:

  • To establish a shelf life for your products
  • As part of Product Quality Reviews (PQRs) to show that the product continually performs as expected

Here are 7 tips we hope will help ease the pain.

1. Prepare a detailed protocol

Ensure that all the documentation is detailed and clear.

Include all important physical, chemical and microbiological parameters.

Ensure the specifications proposed are realistic and fit for purpose.

2. Consider storing extra samples

Storing extra samples at all conditions during a stability trial allows for any additional analysis, e.g. repeat testing, extending the shelf life.

3. Provide a placebo

Even if it is not tested, a placebo stored with a trial may be very useful.

It is not uncommon to have unexpected analytical interference from the placebo during the stability trial.

Having a placebo available may help assess the source of any interference.

4. Control samples

Control product samples stored in refrigerated conditions can be useful when investigating analytical results during a trial.

7. Validation, validation and more validation

All analytical procedures should be fully validated and stability indicating. Therefore build the method validation requirements into your stability protocol to avoid unwanted delays and unexpected costs.

5. Rationalise the testing

For an initial product submission it is advantageous to strictly adhere to the globally accepted stability practices set out in guideline ICH Q1

However it is common practice to minimise the time points for microbiological parameters and elemental assays (e.g. start, yearly and at the end).

6. Take advantage of product grouping

For complementary medicines product grouping is allowable.  With a little scientific justification trials and associated method validations can be grouped for similar products.

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