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STABILITY STUDIES
What Is "Stability Protocol"?How can we help you to determine the shelf life of your product(s)?
Why use our stability services?
What Is "Stability Protocol"?
This is mandated by Health Canada’s Good Manufacturing Practices (GMP). It is to determine the normal shelf life of the product under recommended storage conditions.
How can we help you to determine the shelf life of your product(s)?
We can help, by:
- Preparing a description of the food, drug, or natural health product involved in the study;
- Determining the most appropriate testing parameters, test methods & tolerances;
- Providing documented evidence that these tests are stability-indicating;
- Preparing a list describing all of the required tests for:
- Potency (%active ingredients & preservatives);
- Purity (microorganisms and % moisture); and
- Physical characteristics (odour, taste, tablet disintergration time).
- Determining the number of Lots or Batches to be tested;
- Pre-qualifying & selecting the most appropriate laboratory to perform the tests;
- Ensuring the analytical test procedures are validated in accordance with acceptable methods;
- Determining the most appropriate testing schedule (based on container size & type, dosage strengths, etc.);
- Ensuring the testing lab retains the samples according to written specifications;
- Continually evaluating the stability of these Lots or Batches of the product, by using our internally created statistical spreadsheets; and
- Providing a Summary Report of all the data generated, including the evaluation and the conclusions of the study.
Why use our stability services?
- Allows full-time staff to concentrate on revenue-generating activities;
- No need to hire additional staff, then lay them off after the stability projects have been completed;
- Allows you to bring in our areas of expertise that your company may not have. This will speed up the stability project; and
- Our Stability Summary Report can then be made available as an easy reference for Health Canada to review and approve.