How long should medicine temperature records be kept?

Set retention by checking applicable law, contract and SOP, not a universal number of years.

6 November 2022Updated 23 September 2026

Short answer

Before setting retention, check current law applicable to the product and activity, the customer or quality agreement, and the current SOP. Record the longest applicable requirement, its scope and approver. Define archive access, backup, change history and authorized disposal; do not assume a period.

Do not assume one retention period for medicine temperature records. Requirements can vary by country, product, activity and contract.

Have quality review the current legal provision, quality agreement and site SOP, then approve a period and start date for each record type.

The archive index should identify record type, lot or shipment, owner, storage location, access rights and disposal approval. For electronic records, verify change history and backups too.

Sources

TİTCK, Good Distribution Practice Guide for Medicinal Products (2022)

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Topics:Pharmaceutical cold chain Measurement and traceability Regulations and standards

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Regime, documentation and equipment in pharmaceutical distribution

Pharmaceutical cold chain

How long should medicine temperature records be kept?

Short answer

Sources

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