Processes/Inbound Import Receiving (IIR) Pre-Alert Validation

Step 1 · Email intake

Pre-Alert Inbox

Capture pre-alert emails and thread-level shipment references

Monitor the pre-alert inbox continuously, detect valid subject variants, and extract sender site, invoice id, shipment window, and attachment list into the intake register.

Step 2 · Email intake

Pre-Alert Inbox

Split multi-shipment threads into individual intake units

When one email thread contains multiple invoice shipments, create one intake record per invoice and preserve parent message-id linkage for traceability.

Step 3 · Invoice validation

Commercial Invoice

Validate mandatory regulatory fields on each invoice line

For every line item, verify HTS, FDA Product Code, NDC, ANDA, and unit-of-measure consistency; annotate exact row-level defects instead of broad invoice-level flags.

Step 4 · Invoice validation

Commercial Invoice

Normalize identifiers before document cross-check

Standardize NDC, lot, and supplier naming conventions to an internal canonical format so downstream COA matching and discrepancy emails are unambiguous.

Step 5 · COA verification

COA Documents

Cross-check each invoice batch against COA coverage

Ensure every invoiced batch has matching COA documentation, and verify batch equivalence after known suffix/format normalization rules are applied.

Step 6 · COA verification

COA Documentsmore context needed

Check COA metadata freshness and issuer legitimacy

Validate COA issue dates, issuer signatures, and site code against approved supplier metadata to catch outdated or misattributed quality documents.

Step 7 · Discrepancy reporting

Exception Email

Draft consolidated discrepancy summary per invoice

Compile all defects for the invoice into one structured summary with line references, discrepancy type, and required remediation to minimize back-and-forth.

Step 8 · Closure

Intake Tracker

Log disposition and SLA checkpoint for each intake unit

Record complete/blocked disposition, missing document codes, and SLA checkpoint timestamps so escalations and weekly quality reports are generated consistently.