Labels and records for stored laboratory materials

A label should answer four questions without anyone opening the container: what is it, which batch, how must it be stored, and until when can it be relied on. Behind the label, a record should answer two more: where did this batch come from, and where did it go. ICH Q7, the international guide for active pharmaceutical ingredients, and Health Canada's storage guidance, GUI-0069, set out each piece.

This page describes labelling and record-keeping for materials in a laboratory. Both sources are written for medicines and their ingredients. We quote them to explain good practice, not to claim that any product or site follows them.

What the label should say

ICH Q7 lists the core of a container label in one sentence. It begins:

"Labels used on containers of intermediates or APIs should indicate the name or identifying code"

ICH Q7, section 9.42, retrieved 12 October 2026.

and ends:

"and storage conditions, when such information is critical to assure the quality of intermediate or API."

ICH Q7, section 9.42, retrieved 12 October 2026.

The same guide adds the storage line and the date:

"Special transport or storage conditions for an API or intermediate should be stated on the label."

ICH Q7, section 10.22, retrieved 12 October 2026.

"For intermediates or APIs with a retest date, the retest date should be indicated on the label"

ICH Q7, section 9.43, retrieved 12 October 2026.

Put together, a good laboratory label carries: the name or code, the batch or lot number, the storage condition, and the expiry or retest date. Our page on how long peptides last explains the difference between the two dates.

A label that survives the freezer

Labels on cold containers get wet, frosted and rubbed. GUI-0069 asks for labels that stay readable:

"Make sure labels are printed in indelible ink and are applied securely."

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

In practice: use labels and ink made for cold storage, and do not rely on writing on a cap that may be swapped.

Why the label matters in Canadian law

The Food and Drugs Act defines a label broadly:

"label includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package;"

Food and Drugs Act, s. 2, retrieved 4 October 2026.

"Accompanying" is a wide word, and the definition says the label includes what accompanies a product, not only what is stuck to it. For what the law says a label cannot do, see what "research use only" means in Canada.

Records that hold up

A record is only useful if it can be trusted later. ICH Q7 gives three rules that fit any laboratory notebook or log:

"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.

"The retention periods for these documents should be specified."

ICH Q7, section 6.12, retrieved 12 October 2026.

In plain words: write in ink, never erase, sign and date every change, and decide in advance how long each kind of record is kept.

Tracing a batch

Labels and records meet at the batch number. ICH Q7 asks for a way to follow each batch out of storage. Its sentence begins:

"A system should be in place by which the distribution of each batch"

ICH Q7, section 10.24, retrieved 12 October 2026.

For a receiving laboratory, the same idea works in reverse: log each batch when it arrives, with its supplier, lot number, date received and the certificate of analysis that came with it. If a question comes up later, the record leads straight to the right batch and the right document. Our guide to reading a certificate of analysis explains why the certificate's batch number has to match the label.

Material that is set aside

Sometimes a batch should not be used: it is past its retest date, it was found outside its storage condition, or its label is unreadable. ICH Q7 says:

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

ICH Q7, section 7.44, retrieved 12 October 2026.

In practice: a marked shelf or box, a clear "do not use" label, and an entry in the log saying why. GUI-0069 asks for a written decision after a temperature excursion; see temperature control and records.

A labelling and records checklist

1. Name or code on every container.
2. Batch or lot number, matching the certificate of analysis.
3. Storage condition.
4. Expiry or retest date.
5. Indelible ink, securely applied.
6. A receiving log: supplier, lot, date, certificate.
7. Records in ink, corrections signed and dated, retention period set.
8. A marked quarantine place for material set aside.

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

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