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Hold reserve samples

A reserve sample is physical stock you set aside from a batch and keep, so that if someone questions the batch later you can retest the actual material rather than argue from paperwork. For dietary supplement manufacturers 21 CFR 111.83 requires it, and requires you to keep each sample for a defined period.

SKU.io tracks the sample, works out how long you have to keep it, and — importantly — takes those units off the shelf so they can't be sold by accident.

Before you begin​

  • The lot must exist, and have units remaining.
  • You need permission to manage quality data.

Steps​

  1. Open the lot and go to the Samples tab.

  2. Click Add sample.

  3. Fill in the sample:

    • Sample — your identifier for the physical sample, such as RS-CB-2608-A-01. Whatever is written on the container.
    • Retained — the date you set it aside.
    • Quantity and Unit — how much you pulled. This is what gets held.
    • Location — where it physically is, for example QA cabinet B, shelf 2. This is the field that saves you when someone has to actually go and find it.

  4. Leave Retain until blank unless you need to override it. SKU.io computes it for you — see below.

  5. Click Save.

The sample appears in the list, and its Held column shows the units now reserved. Click that number to open the stock hold it created.

How long the sample is kept​

Left blank, Retain until is computed as one year past the lot's expiry date — which is what 21 CFR 111.83 requires for a product with a shelf-life date. A lot expiring 19 February 2027 gets a retain-until of 19 February 2028.

The point is that nobody has to remember the rule or do the arithmetic. You can still type a date yourself if your own policy is longer, and an entered date is recorded as a deliberate choice rather than a computed one.

The units come off the shelf​

This is the part worth understanding, because it's the difference between a record and a control.

When you retain a sample, SKU.io places its quantity on a stock hold against the lot. Those units drop out of available-to-promise, so they can't be allocated to an order or picked. Without that, the sample exists only as a note — and the two bottles sitting in your QA cabinet are still counted as sellable stock, which is how a reserve sample gets shipped to a customer.

The hold follows the sample's status:

StatusUnits held?Use it when
RetainedYesThe sample is in your cabinet, retention clock running
Sent to LabYesIt's out for third-party testing — still yours, still not sellable
ReturnedYesIt came back after testing
DiscardedYesIt was destroyed after the retention period

Note that Discarded still holds the units. That looks wrong at first glance and isn't: the sample was physically destroyed, so those units are gone. Releasing the hold would put them back into available-to-promise as if they were on the shelf, and you'd promise a customer stock that no longer exists.

Sending a sample to a lab​

Change the sample's status to Sent to Lab. A Lab name is then required — a sample can never be recorded as "somewhere" without a named custodian. Add the date it went and a tracking number if you have one.

When it comes back, set the status to Returned.

Disposing of a sample​

Once the retain-until date has passed, set the status to Discarded and record the disposition — what was done with it and when. That note is the evidence that the sample was kept for its full period and then disposed of properly, which is exactly what an inspector asks about.

Next steps​

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