If there is a slight change in drug substance storage temperature, what is the recommended action to take?

When there is a slight change in the drug substance storage temperature, the recommended action is to submit the change with the required documents and rationale. This is important because even minor alterations in storage conditions can potentially impact the stability, efficacy, and safety of the drug product. Regulatory guidelines often require that any changes to manufacturing processes or storage conditions be documented and assessed to ensure compliance with established specifications and regulations.

Submitting the change with appropriate documentation allows for thorough evaluation and ensures that any potential impacts on the product are considered. The rationale behind the change must also be provided to demonstrate that the adjustment will not adversely affect the quality or performance of the drug substance. This process helps maintain data integrity, adherence to good manufacturing practices (GMP), and compliance with regulatory obligations, ensuring that patient safety remains the top priority.

Additionally, while other options may include various forms of internal documentation or consulting with teams, they do not fulfill the regulatory requirements of formally notifying and documenting changes as necessary. Ignoring the change or merely documenting it internally can lead to oversight and potential regulatory issues later on.