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Form · VAL-F07

Temperature Excursion Investigation Report

Excursion details, product impact assessment, disposition and CAPA.

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Purpose

The investigation report for a temperature (or humidity) excursion: definition of the excursion from monitoring data, products and batches affected, cause, product impact assessment with reference to stability data or manufacturer assessment, disposition decision, CAPA and closure, per VAL-P08.

What it covers

  • 1. Excursion definition
  • 2. Cause
  • 3. Products affected and impact assessment
  • 4. Disposition
  • 5. CAPA and closure
  • Authorisation

How to complete it

  1. 1.Open within one working day of an excursion beyond the storage limit; number EXC-YY-NNN.
  2. 2.Define the excursion from EMS data (not the alarm time); attach the trend; compute duration outside limits and MKT.
  3. 3.List every product / batch present with quantities; assess impact individually; attach the stability data or the manufacturer's written assessment.
  4. 4.Record disposition and the approver; record CAPA (SOP-05) and close within 30 days with QA approval.

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.