Hand Sanitizers and Stability Testing

By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email

Alcohol based Hand Sanitizer COVID 19 interim measures were removed by Health Canada in July 2020.  This means that the once exempt need for stability data to support your shelf life and expiry date, is now required and there has been a significant rush to laboratories to get product lots set up on a stability program to support the shelf life and expiry date on your product.

So what happens when your stability data starts to show you that your product is in specification for longer time frames?  Perhaps you have a 6 month expiry date and your stability data is now showing you can have a 1 year shelf life but all your current inventory is showing 6 months. While guidance on this particular situation is not written out in the NHP GMP guidance document, you can over-label your products with the updated expiry date as long as you follow a few critical steps:

• You have stability data that fully supports an increase in expiry date (based on actual stability of your product in it’s finished packaged form) and it is approved by your Quality Assurance Manager
• You have an NHP Site License for Packaging and Labelling
• You have a signed Standard Operating Procedure that is written and followed for handling over-labelling/rework including documenting all details such as:
  • the quantities being over-labelled
  • lot codes being over-labelled
  • final inspection report of the over-labelling
  • you keep all records on file to at least 1 year past the new expiry date
• The process is fully approved and supervised by your Quality Assurance Manager or designate.
• The process is done in a clean designated part of the facility using staff trained to handle NHP products.

If you have any questions on your NHP Hand Sanitizer stability program Dell Tech can help you navigate the requirements.

Contact:
Dell Tech Laboratories
Jacqui Jenskey
Senior Regulatory Affairs Specialist
519-858-5021 x 2028
jjenskey@delltech.com

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