Depot packaging and external labels

Purpose

Connect a product lot to its approved external-label model and distinguish creating stock from releasing packaged supply.

Expected outcome

You can explain why new lots remain in Packaging, how label/master mapping differs by supply model and why completion requires an authorized signature.

Prerequisites

Correct study, configured product and authorized unblinded inventory/packaging access. Applicable randomized workflows require a saved master schedule. Approved label instructions and packaging records must be available.

Section 1: Prepare the lot

1. Open Inventory and choose Lots.
2. Define the product, lot number, expiry, quantity and required handling parameters using the approved records.
3. Check whether the product is arm-linked or non-randomized.
4. Choose the supported mapping approach and prepare the permitted label file if needed.

When an existing released lot of the same Investigational Product establishes the primary external kit-label identifier, follow the retained product labeling convention for new depot-packaging lots.

Section 2: Mapping and supply models

• Individually tracked randomized supply must preserve appropriate master-ID and treatment/product matching.
• Supported CSV/XLSX label import checks the required structure, identities and arm matching rather than accepting arbitrary labels.
• Single-arm quantity supply uses a shared kit identity with physical quantity balances.
• A product unlinked to every treatment arm is recorded as non-randomized at lot creation; it requires no Randomization Schedule.
• Lot classification is retained even if the study design later changes.

Section 3: Complete packaging and release

1. Review generated/imported mapping against physical labels and approved packaging instructions.
2. Retain the mapping output supplied by the workflow, including the immutable stored mapping PDF when applicable.
3. Complete packaging with the required authentication and reason.
4. Confirm released status and stock eligibility before shipment.

Release does not override expiry, quarantine, Do-Not-Ship windows or handling restrictions. Ordinary report PDFs are different from the workflow's retained immutable mapping PDF.

Troubleshooting and checks

Investigate label mismatches; do not rewrite the master assignment list to fit a label file. Non-randomized lot support does not introduce a standalone rescue-medication prescribing workflow. Do not delete operationally referenced lots to correct packaging history.