Business Central Quarantine Lots and Quality Release: GMP Guide

A pallet of Vitamin C 500 mg, Lot L-24071, comes off the trailer on Monday. Your QC test takes three days. Until Quality Assurance releases the lot, nobody should be able to pick it, consume it or ship it, and an auditor should later see who released it, when, and on what basis.

This guide walks through a Business Central quarantine lot process on a GMP floor.

What a GMP hold and release process has to do

A lot hold and quality release in Business Central, or in any ERP, has four jobs.

1. The hold stops every outbound path. Not only sales shipments: warehouse picks, production consumption, transfers and journal postings too.
2. QC and QA are separate steps. Quality Control records results. Quality Assurance reviews them and decides. One person may hold both roles, but the system should know which role made which decision.
3. The decision is signed. The record shows who decided, when, and what the signature means, such as “released” or “rejected”.
4. The record cannot be quietly changed. If a decision is corrected, the original stays visible.

What standard Business Central gives you

Item tracking codes. With Lot Specific Tracking on, every outbound unit must be tied to an existing lot number. Lot Warehouse Tracking is needed to handle lot numbers in warehouse documents.

Expiration dates. Use Expiration Dates on the item tracking code turns on expiry checks. Business Central can calculate the date from the Expiration Calculation formula on the item card, unless Require Expiration Date Entry forces the user to type it. With Strict Expiration Posting, the expiration date recorded when the lot entered inventory is enforced when it leaves: you cannot post a sales order for an item past its expiration date.

Pick According to FEFO. Turned on for the location, it sorts items with Lot Warehouse Tracking that were posted with an expiration date earliest first in picks and movements. Warehouse picks also need Bin Mandatory.

The Blocked field. The Lot No. Information Card has a Blocked field, and in standard Business Central it freezes the lot completely. Creating an inventory pick or a warehouse pick leaves the blocked quantity out, registering a pick, an inventory pick or an inventory movement checks it, and any item posting with a blocked lot fails, transfers and reclassifications included.

Quality Management. Since Business Central 2026 release wave 1, Microsoft publishes a Quality Management app, preinstalled on new environments. It creates inspections at purchase receipts, production and assembly output, and warehouse movements. Workflows can block a lot when an inspection is created and unblock it on a pass. Inspection results can also allow or block each transaction type separately, from sales and transfers to picks, put-aways and movements, so a failed lot can still be transferred to quarantine. Failed stock can be moved to quarantine bins, written off, transferred or returned to the vendor. Only a user with the Quality Admin & Supervisor permission set can reopen or delete a finished inspection.

On Dynamics 365 Supply Chain Management (Finance and Operations), quality management is a different module, covered in Dynamics 365 Quality Management for Manufacturers.

Where the gaps show on the warehouse floor

Standard features work on documents and lot cards. GMP problems show up at the pallet and the scanner.

Part of a lot on hold. A forklift damages four cases of L-24071; the other 36 are fine. Blocked sits on the lot number card, so it applies to the whole lot number. Package tracking can hold part of a lot through a blocked Package No. Information card, but only if the item was set up for package tracking from the start and the damaged cases already carry their own package number. Otherwise holding them means a reclassification posting to a new lot or package that exists only because of the hold.

Status checked at the scan. In standard Business Central, a blocked lot is left out when the pick is created and refused when the pick is registered or posted. Typing a blocked lot on a pick line raises no error until registration, so the picker finds out at the end of the pick, not at the pallet.

Quarantine bins. A bin called QUARANTINE only protects stock if the system refuses picks from it. In WMS setups, Microsoft documents a QC bin type whose content stays out of the normal item flow. Elsewhere, treat a quarantine bin as a label and rely on the lot block behind it. One catch: because Blocked stops every item posting, a blocked lot cannot be transferred or reclassified to a quarantine location until someone unblocks it.

Who can unblock a lot. Any user who can edit the Lot No. Information card can clear Blocked, and the change log records who did it only if you set it up for that table.

Near-expiry rules per customer. One retailer wants 12 months of remaining shelf life, another accepts 6. Standard Business Central has no per-customer minimum remaining shelf life: the customer card has no such field, and Strict Expiration Posting only compares against the expiration date.

More on warehouse options: our WMS guide for manufacturers and distributors.

A practical status model: Available, Hold, Quarantine, Rejected, Expired

A Blocked checkbox answers yes or no. A GMP site needs to know why.

Two rules make it work: every transition is a decision with a user, a time and a reason, and only Available stock is offered to a pick.

Keep Hold and Quarantine apart. Hold is the normal state of a new receipt; Quarantine says something went wrong. A hundred lots on Hold is a normal Tuesday. Ten in Quarantine is a trend.

Expiry control from receipt to pick

Lot expiry and quarantine in Business Central are best handled at four points.

At receipt. Capture lot and expiry from the supplier label and check them against the item’s shelf-life rule. A lot that arrives with 9 months left when your rule asks for 18 should stop at the dock, not turn up in a cycle count.

In storage. Someone has to see what expires in the next 30, 60 and 90 days and start re-tests in time. The standard Item Expiration - Quantity report groups on-hand stock of expiry-tracked items into periods.

At allocation. Apply the customer’s minimum remaining shelf life before a lot is promised to an order.

At the pick. FEFO by default. To block expired lots, Business Central relies on Strict Expiration Posting: with FEFO on, only lots that are not expired are included in the pick. Picking a newer lot than FEFO suggests should take a specific right and a reason code, with both lot numbers logged.

Electronic signatures and audit trail in 21 CFR Part 11 environments

In 21 CFR Part 11, section 11.50 requires a signed electronic record to show the signer’s printed name, the date and time, and the meaning of the signature, such as review or approval. Section 11.10(e) asks for secure, computer-generated, time-stamped audit trails, where changes “shall not obscure previously recorded information”.

Standard Business Central covers part of the audit trail. The change log records who changed which field and when, with old and new values, for the tables you choose. Microsoft’s Quality Management app records who finished an inspection and when, and it can route inspections through standard approval workflows, where an approval entry records the user and the time. There is no re-authentication and no stated meaning captured at the moment of the decision.

Microsoft also states that no certification exists for complying with Part 11, and that customers who deploy applications subject to FDA regulation are responsible for meeting FDA requirements.

How Modax WMS handles this inside Business Central

Modax WMS is one Business Central extension, and the handheld is a screen of Business Central. It posts standard Business Central documents.

• Five lot statuses: Available, Hold, Quarantine, Rejected, Expired. A pick is only sent to available stock. A posting made in Business Central outside the handheld cannot take stock on hold, and a lot entirely on hold shows as blocked on its lot card.
• Two-step disposition: QC records, QA releases, and one person holding both roles does it in one step. Roles are set per worker and every role change is logged. The disposition is signed on the handheld and cannot be edited or deleted.
• Hold in the storage bin: put-away on hold is chosen per item on the quality policy. Pallets with long tests go to their storage bin on hold instead of waiting at the dock, and no pick is sent to them.
• Part of a lot on hold: the same lot on a license plate of its own, with its own status, while the rest stays available.
• Expiry Watch: shows what expires next and what it is worth, blocks expired lots and starts the re-test, with a new date when Quality sets one.
• Non-conformance records: return to vendor, scrap, rework or use as is, with containment, justification and history.
• Receipt checks: lot and expiry are entered at receipt and checked against the item’s shelf-life rule.
• FEFO on every pick: a newer lot needs the override right and a reason code, and the log keeps both lots, the user and the time. An expired lot is never offered to a pick.
• Minimum remaining shelf life per customer: lots below it are passed over at allocation and refused at the scan.

For regulated sites, the Compliance Pack adds the electronic signature, designed for 21 CFR Part 11 environments. Quality decisions and status changes are signed with a PIN and a stated meaning; a PIN locks after repeated failed attempts, and every attempt is on record. The pack also delivers validation documentation with every release: functional specification, test scripts and a requirement-to-test traceability matrix. Validation itself remains your responsibility.

Checklist for your hold and release process

• Does a hold stop picks, consumption, transfers and journal postings?
• Can part of a lot stay on hold while the rest ships?
• Is the status checked when the pallet is scanned?
• Are QC and QA separate, signed steps, and is every unblock logged?
• Is expiry checked at receipt, and customer shelf-life rules at allocation?
• Does picking a newer lot than FEFO suggests need a right and a reason?

If several answers are “not yet”, see how Modax WMS runs the process, or contact us to walk through your receiving, quality and picking flow on the handheld.