Receiving Materials to Production

This workflow covers the full journey of a raw material lot — from the supplier shipment arriving at your facility through QA quarantine review, lot release, and final assignment to a batch step. Understanding this flow is essential for maintaining 503B supply chain traceability.

Process overview

Step 1 — Receive the lot

Role required: Warehouse / Receiving Technician

1. Navigate to Inventory → Receiving and click New Receipt.
2. Select the material from the catalog or create a new one if it is the first shipment.
3. Enter the following fields:
   • Supplier — select from the approved supplier list
   • Lot number — as printed on the supplier label or COA
   • Quantity received and unit of measure
   • Expiry date (mandatory for GxP materials)
   • COA reference — attach the PDF or enter the document number
4. Save the receipt. Clarix creates the lot with status Quarantine and generates a lot label for your facility barcode.

Note: If the shipment is a partial delivery, enter only the quantity physically received. You can add subsequent partial receipts against the same purchase order later.

Step 2 — Quarantine period

Role required: Warehouse Technician, QA Officer

1. The lot is physically segregated in the quarantine area (labeled with the Clarix lot barcode).
2. QA is notified automatically via the Pending QA Review queue under Inventory → Lots.
3. During the quarantine period, the lot cannot be assigned to any batch.
4. If your SOP specifies a minimum hold time before QA review, note the receipt date on the physical label.

Step 3 — QA release

Role required: QA Officer

1. Navigate to Inventory → Lots and open the lot pending review.
2. Review the attached COA against your in-house specifications:
   • Identity, purity, potency, and microbial limits as applicable
   • Certificate of Analysis must match lot number and expiry on the physical container
3. Inspect the physical lot for container integrity, labeling, and storage conditions.
4. If the COA and inspection pass:
   • Click Approve Lot. Status changes to Released.
   • The lot is now available in the inventory pool for batch assignment.
5. If the COA or inspection fails:
   • Click Reject Lot and enter a rejection reason.
   • Status changes to Rejected. The lot is blocked from any future use.
   • Initiate a Deviation if required by your SOP and coordinate with the supplier for return or disposal.

Step 4 — Batch creation with lot assignment

Role required: Batch Technician

1. Navigate to Batches → New Batch and select the formula.
2. For each component in the batch, the lot assignment panel shows all Released lots for that material sorted by expiry (FEFO order).
3. Select the lot to use and enter the quantity to draw.
   • Clarix validates that sufficient on-hand quantity is available.
   • Multiple lots can be assigned to a single component if needed (split lot).
4. Save the batch. Lot reservations are recorded against each assigned lot.

Note: Lot assignment can be completed at the time of batch creation or deferred to the individual step where the material is dispensed, depending on your facility SOP.

Step 5 — Barcode scan during batch step execution

Role required: Batch Technician

1. During step execution, when a component dispensing step is reached, the technician scans the lot barcode using the Clarix mobile app or a connected scanner.
2. Clarix cross-references the scanned lot against the assigned lot for that step.
3. If the scans match, the usage is confirmed and the dispensed quantity is recorded.
4. The lot's on-hand balance is decremented automatically upon step completion.

Edge cases

Quarantined lot scanned during a batch step

If a technician scans a lot that is still in Quarantine status during a batch step, Clarix displays a prominent alert with an acknowledgment checkbox. The technician must:

1. Read the alert, which states the lot has not been QA-released.
2. Check the acknowledgment box to confirm they understand the exception.
3. The acknowledgment — including the user identity and timestamp — is recorded in the step's supplementalData for audit traceability.

Edge case: The batch cannot proceed past that step without the QA acknowledgment being recorded. QA must subsequently review the batch exception before the batch can be approved.

Expired lot

Lots past their expiry date are automatically blocked from assignment and from being scanned into a batch step. Clarix displays an expiry block error. The lot must be:

• Quarantined physically and marked for rejection/disposal in Clarix
• A deviation raised if the lot was previously in active use when discovered to be expired

Partial shipment

If only a portion of the ordered quantity arrives:

1. Enter only the received quantity when creating the lot receipt.
2. The purchase order balance remains open.
3. When the remainder arrives, create a second receipt under the same purchase order. Clarix links both receipts to the order.
4. Each receipt can have a separate lot number if the supplier ships from different production lots.

Failed COA

If QA rejects a lot due to a failed COA:

1. Enter the rejection reason in detail (e.g., "Potency below specification: result 97.1%, limit ≥99.0%").
2. Clarix records the rejection event with the QA user, timestamp, and reason.
3. Create a Supplier Deviation to document the out-of-specification shipment.
4. The supplier is notified per your SOP; coordinate return or destruction.
5. The rejected lot is permanently blocked from inventory use.

Related pages

• Receiving Lots
• Lot Management
• Components and Lots
• Executing Steps