Temperature control and records for stored materials

A storage condition on a label only means something if the material has actually been kept that way. The only way to show it is to measure the temperature and write it down. Health Canada's guidance on storing and transporting drugs, GUI-0069, describes the pieces: monitor where it matters, calibrate the devices, keep records of readings and alarms, and make a written decision whenever the temperature goes outside its range.

This page describes record-keeping for stored materials in a laboratory. GUI-0069 is written for drugs. We quote it to explain good practice, not to claim any product or site follows it.

Who the guidance is for

GUI-0069 sets its own scope widely:

"These guidelines apply to all persons (individuals and companies) involved in the storage and transportation of drugs."

Health Canada, GUI-0069, section 1, retrieved 12 October 2026.

And it states the aim in one line:

"Measures need to be taken during storage and transport to abide by these required conditions."

Health Canada, GUI-0069, section 4.1, retrieved 12 October 2026.

The "required conditions" are the ones on the label; see how to store lyophilized peptides in the lab.

Monitor at the right spots

A fridge or freezer is not the same temperature everywhere. The door, the back wall and the top shelf can differ. GUI-0069 asks for that to be found out first:

"Identify those areas through temperature mapping, and ensure you are monitoring at the most appropriate locations."

Health Canada, GUI-0069, section 5.1, retrieved 12 October 2026.

Temperature mapping means measuring at several points over time to see where the warm and cold spots are. The probe then goes where the risk is, not where it is easiest to reach.

Calibrate the devices

A reading is only as good as the device that took it. GUI-0069 says:

"Calibrate any devices that monitor temperature and humidity (such as data loggers) at predetermined intervals."

Health Canada, GUI-0069, section 5.2, retrieved 12 October 2026.

"Maintain calibration and maintenance records for monitoring equipment."

Health Canada, GUI-0069, section 5.5, retrieved 12 October 2026.

"Predetermined intervals" means a schedule set in advance, not a check when someone remembers. Keep the calibration certificate with the device's records.

Keep the readings and the alarms

The core record is short:

"Keep temperature monitoring records and notes of any alarms."

Health Canada, GUI-0069, section 5.1, retrieved 12 October 2026.

A data logger that records automatically, with its file kept, meets the spirit of this better than a once-a-day glance. The alarm notes matter as much as the readings: what went off, when, and what was done.

When the temperature goes out of range

An excursion is a period outside the stated range. GUI-0069 does not say an excursion means a material is spoiled, or that it is fine. It asks for a decision on the record:

"If temperature excursions occur, assess and document them to determine whether or not to accept or reject the product."

Health Canada, GUI-0069, section 5.3, retrieved 12 October 2026.

In plain words: write down how far out, for how long, and on what basis the material was kept or set aside. ICH Q7, the international guide for active ingredients, says how material that is set aside should be handled:

"Rejected materials should be identified and controlled under a quarantine system"

ICH Q7, section 7.44, retrieved 12 October 2026.

Transport is storage too

A material is still being stored while it is in transit. GUI-0069 asks for the process to be written:

"Establish written procedures for the transportation of drugs."

Health Canada, GUI-0069, section 5.2, retrieved 12 October 2026.

ICH Q7 states the aim:

"APIs and intermediates should be transported in a manner that does not adversely affect their quality."

ICH Q7, section 10.21, retrieved 12 October 2026.

A receiving laboratory can do its part: check the package on arrival, note the time, read any indicator or logger in the shipment, and move the material to its storage condition without delay.

How to write a record that holds up

ICH Q7 sets simple rules for any record:

"When entries are made in records, these should be made indelibly in spaces provided"

ICH Q7, section 6.14, retrieved 12 October 2026.

"Corrections to entries should be dated and signed and leave the original entry still readable."

ICH Q7, section 6.14, retrieved 12 October 2026.

In practice: pen, not pencil; a line through a mistake, not correction fluid; a date and initials beside every change.

Why records connect to shelf life

ICH Q1A(R2), the stability guideline, defines the tolerance a storage condition allows in stability studies:

"The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies."

ICH Q1A(R2), glossary, storage condition tolerances, retrieved 12 October 2026.

A shelf life holds only under the stated condition; see how long peptides last. The temperature record is how you show the condition was kept.

None of this says whether a material may be bought or sold in Canada; for that, read are peptides legal in Canada?.

More in the handling series: labels and records for stored materials. Get the free library updates by email.