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Cold chain breach reporting form

Cold chain breach reporting form

Document temperature excursions affecting pharmaceutical products with comprehensive incident tracking and regulatory compliance reporting.

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Cold chain breach reporting form

Document temperature excursions affecting pharmaceutical products with comprehensive incident tracking and regulatory compliance reporting.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

Our cold chain breach reporting form helps you document temperature excursions that affect pharmaceutical products and vaccines. When temperature-sensitive items deviate from their required storage conditions (typically 2-8°C), this template guides you through recording critical incident details: duration, temperature range, affected products, and corrective actions.

According to the World Health Organization, up to 25% of vaccines are wasted globally due to cold chain failures. This standardized form ensures you meet regulatory compliance requirements while providing a clear record for quality assurance teams to determine if products remain viable. When a refrigeration unit malfunctions overnight, this template helps you quickly assess impact, document the breach, and make informed decisions about product integrity.

Related categories

Created by

Author Name Inioluwa Ademuwagun
Preview of the template
Entity
General Information
Date of Breach
Time of Breach
Product Name
Lot Number
Expiry Date
Quantity Affected
Location of Breach
Breach Details
Describe the nature of the breach
How long was the product exposed to inappropriate temperatures?
What was the minimum/maximum temperature reached?
Was the breach detected immediately?
Reason for breach
Corrective Actions
What immediate actions were taken?
What long-term preventive actions will be implemented?
Was the product quarantined?
Was the product destroyed?

Frequently asked questions

What information should I include when documenting a cold chain breach?

Document the date and time of discovery, duration of exposure, minimum and maximum temperatures recorded, affected products with lot numbers, previous storage conditions, and immediate actions taken. Include equipment details, monitoring method used, and whether temperature logs are available for review by quality assurance personnel.

How quickly should I complete a cold chain breach report after discovering the incident?

Complete the report immediately after discovering the breach while details are fresh. Most regulatory bodies require reporting within 24 hours, but the sooner you document the incident, the more accurate your information will be. Prompt reporting also enables faster decision-making about affected product disposition.

What temperature monitoring information should I attach to my cold chain breach report?

Attach all available temperature logs showing the breach pattern, including data logger readings if available. Include minimum and maximum temperatures recorded, duration above or below acceptable range, and any graphical representations of the temperature excursion. This evidence helps manufacturers assess product stability.

Author
Inioluwa Ademuwagun
Inioluwa is a freelance content writer with a passion for words and everything marketing. She has worked closely with B2B SaaS and e-commerce brands creating product-led content. She loves to read fiction and would describe herself as an introverted nerd who desires to travel around the world. She currently doing that with her words till she can with her eyes
This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.