Components and Lots

The Components tab on a batch detail page is where you link physical inventory lots to the batch. Issuing a lot to a batch creates a permanent traceability record — proving exactly which raw material (from which vendor, with which COA) went into each unit you produced.

The Components tab

Navigate to the batch detail page and click the Components tab. You will see all Bill of Materials (BOM) lines from the Master Formula listed as rows, each with:

• Component name — the raw material as defined in the formula BOM
• Target quantity — the amount required per the formula (adjusted for batch size)
• Issued lot — the inventory lot assigned to this BOM line (empty until issued)
• Actual quantity issued — what was physically weighed and recorded
• Status — whether a lot has been issued for this line

Issuing a lot to a batch

Role required: Compounding Technician or above.

A lot must be in Released status to be issued to a batch. Quarantined, Rejected, or Recalled lots cannot be issued.

1. On the Components tab, find the BOM line for the material you want to issue.
2. Click Issue lot on that row.
3. An Issue Lot dialog opens showing available Released lots for that material. The list is ordered by expiry date (FEFO — first expired, first out) to encourage first-in, first-out usage.
4. Select the lot you want to issue.
5. If the lot has a barcode registered in the system, you will be prompted to scan the barcode to confirm you have the correct physical container. Scan with your device camera or USB scanner.
6. Enter the quantity issued (the actual amount you weighed or measured for this batch).
7. Click Issue lot.

The lot is now linked to this BOM line. The quantity entered is deducted from the lot's available inventory balance immediately.

Issue Lot dialog fields

FEFO policy

Clarix defaults to FEFO (First Expired, First Out) ordering in the lot selection dropdown. The lot with the earliest expiry date is listed first and is the pre-selected default.

• You can select a later-expiry lot from the dropdown if operationally justified — for example, if the FEFO lot quantity is insufficient for the full batch.
• Any deviation from FEFO should be noted in the Issue reason field for audit trail purposes.
• The FEFO policy threshold is configurable in Settings → Inventory Policy — organizations can require approval or a written justification when selecting a non-FEFO lot.

Note: Selecting a non-FEFO lot does not block issuance, but will generate an audit trail entry noting the FEFO deviation if your policy requires it. Always document the reason for selecting a later-expiry lot.

Barcode confirmation

When a lot has a barcode on file, barcode confirmation is a required verification step before the lot can be issued. This prevents inventory mix-ups — ensuring the physical container in your hands matches the lot you selected in the system.

Two scan methods are supported:

• Camera scan — uses the iPad or mobile device camera to scan a barcode or QR code on the container label.
• USB scanner input — for facilities using a connected USB barcode scanner at a workstation; the scan input populates the confirmation field automatically.

If the scanned barcode does not match the expected lot barcode format configured for that item, an error is displayed and the lot cannot be issued until a matching scan is recorded.

If a barcode scan is not possible (scanner unavailable, barcode damaged or unreadable), a Supervisor can override with a PIN and written reason. The override is permanently recorded in the audit trail, including the supervisor's identity, timestamp, and stated reason.

COA assay and purity calculations

The COA (Certificate of Analysis) assay percentage recorded when the lot was received is automatically applied to any Calculation steps in the batch that reference the purity variable.

For example, if you received Famotidine USP with a COA assay of 97.2%, the purity factor used in calculations will be 0.972. A calculation step with the expression targetWeight / purity will automatically compute:

50,000 mg / 0.972 = 51,440 mg  (adjusted quantity to compensate for purity)

This ensures that when your technician weighs the adjusted quantity, the final batch contains the correct amount of active ingredient regardless of lot-to-lot purity variation.

Important: If the COA assay was not entered when the lot was received, the purity factor defaults to 1.0 (100%). This may produce incorrect calculations. Always enter the COA assay when receiving a new lot.

Inventory deduction

When a lot is issued to a batch, the quantity is immediately deducted from the lot's On Hand balance in inventory. This ensures that:

• Other batches being created at the same time do not over-commit the same material
• The inventory catalog accurately reflects what is physically available
• Expiring lot alerts reflect true remaining quantities

If a batch is voided after a lot has been issued, the quantity is automatically returned to the lot's on-hand balance.

Changing or removing an issued lot

If you issued the wrong lot or entered an incorrect quantity, you can update the assignment while the batch is still In Progress:

1. On the Components tab, click the issued lot row.
2. Click Re-issue to select a different lot or update the quantity.
3. Enter the reason for the change.
4. The original issuance and the correction are both recorded in the audit trail.

You cannot remove a lot issuance once the batch has been submitted for QA review.

Viewing lot details from within a batch

Click any issued lot number (shown as a link in the Components tab) to open that lot's detail page in a new tab. This lets you review the full COA, prior batch usage, and remaining quantity without leaving the batch.

Lot substitution

A lot substitution occurs when the formula specifies one material (e.g., Material A from Vendor X) but an equivalent material from a different source (e.g., Material B from Vendor Y — same active ingredient, different manufacturer) needs to be used in its place.

Lot substitutions are quality events and require documented justification:

1. QA authorization is required before using a substitute material. Do not proceed with substitution without QA sign-off.
2. Open a deviation documenting the substitution reason (e.g., "Material A stock exhausted; substituting Material B per QA approval #DEV-2026-0042").
3. In the Issue Lot dialog, select the substitute item's lot from the lot dropdown. The system will display a warning if the item code does not match the BOM line item — acknowledge the warning and enter the deviation reference in the Issue reason field.
4. The deviation links to the batch record and the specific BOM line where substitution occurred.
5. Review with the PIC before continuing batch execution. The PIC's review should be documented (via a signature step or notation in the batch record).

Note: Using a lot from a different item than specified in the BOM is recorded in the audit trail as a substitution event, regardless of whether a deviation is formally opened. Always open a deviation — relying only on the audit trail entry is not sufficient for GxP compliance.

Related pages

• Executing Steps — How steps reference issued lots via barcode scans
• Inventory — How lots are created and released before use
• Step Types — Barcode Scan — Scanning barcodes during step execution