It is a regulatory requirement to control environmental parameters such as temperature and humidity (where required) throughout the supply chain of Health products. Health products are required to be kept according to their labeled storage conditions and any excursions beyond the labeled conditions can affect product quality. The impact on product quality should be investigated and assessed for suitability to remain in the market with supporting data. Click on the link below to find out more about requirements.
Click here to find out more about the requirements in Canada:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guidelines-temperature-control-drug-products-storage-transportation-0069.html#s2.1.1
Source: www.canada.ca
