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Notification of Temperature Deviation Form Site Name: Site Number: In the event of an incident that may threaten the integrity of the Metabolic Substudy specimens such as a power failure/freezer failure,
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Step 1: Start by identifying the temperature excursion, which is a deviation from the recommended temperature range.
02
Step 2: Gather all the necessary documentation, including the product's temperature requirements and any specific handling instructions.
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Step 3: Evaluate the impact of the temperature excursion on the product, considering factors like the duration and degree of deviation.
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Step 4: Communicate the temperature excursion to the relevant parties, such as the quality assurance team or the manufacturer.
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Step 5: Follow the recommended corrective actions outlined in the handling instructions, which may involve reconditioning the product or conducting additional tests for quality assurance.
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Step 6: Document all the actions taken during the handling of the temperature excursion for future reference and auditing purposes.

Who needs handling temperature excursions and?

01
Any individual or organization involved in transporting or storing temperature-sensitive products needs to be aware of handling temperature excursions.
02
This includes pharmaceutical companies, biotech firms, food and beverage distributors, logistics providers, and healthcare facilities.
03
Anyone responsible for maintaining the quality and efficacy of temperature-sensitive products can benefit from knowing how to handle temperature excursions.
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Handling temperature excursions refers to managing instances where the temperature of a product or environment goes outside the specified range.
Anyone responsible for overseeing the storage or transportation of temperature-sensitive products may be required to file handling temperature excursions.
Filling out handling temperature excursions involves documenting the details of the excursion, including the date, time, location, products affected, and actions taken.
The purpose of handling temperature excursions is to ensure that product integrity is maintained and potential risks are addressed promptly.
Information such as the cause of the excursion, measures taken to rectify the situation, and any impact on product quality must be reported on handling temperature excursions.
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