Workflow guides

GMP lot tracking and quarantine: lot chain, FEFO, four-eyes approval

In Manufio every finished lot is linked by recorded connections to its work order, formula version and consumed raw material lots. Goods in quarantine never enter saleable stock until they are released.

Lot tracking is more than writing a number: after a complaint you must go backwards, in a recall forwards. Quality decisions also need to stay on record with a person and a time.

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How it works

  1. 01

    Lot records

    Raw material lots open at receipt, finished lots in production; the lot used is recorded when a task is accepted.

  2. 02

    Quarantine

    The quarantine queue shows product, lot, source work order, days waiting and the issue; release, rework or scrap is recorded with a reason.

  3. 03

    Audit trail

    The person who opens cannot approve; every settings change is kept with who, when, old and new value.

Problems from the factory floor

QualityHard gate

Quarantine gate

ProblemNobody could tell what was in quarantine; the screen only offered a “release” button.

SolutionThe quarantine queue shows product, shade, lot, quantity, the work order it came from, how many days it has waited and the issue. Goods that have not been released never enter saleable stock.

Quality

Lot chain

ProblemA complaint comes in about a batch. Which raw material lot, from which supplier, went into it?

SolutionOne screen leads from the finished lot to the work order, the formula version and the consumed raw material lots. Lots are recorded when a task is accepted, so the view shows recorded links, not assumptions.

Quality

FEFO: first expiry, first out

ProblemLots close to expiry stayed on the shelf while newer deliveries were used first.

SolutionConsumption uses the lot that expires first. Expired lots do not count as free stock, and lots nearing expiry trigger a notification every morning.

QualityHard gate

Four-eyes principle

ProblemPeople were closing requests they had opened themselves and approving their own purchase orders.

SolutionThe person who opens cannot be the one who approves: lab analysis and approval, R&D requests, purchase orders above a threshold, a second chemist’s approval for large batches. Thresholds live in settings; once a threshold is exceeded, the rule applies even if the general switch is off.

Quality

Settings audit trail (ALCOA)

ProblemIf someone quietly changes the setting behind a gate, who notices, and when?

SolutionEvery settings change lands in the audit trail with who, when, old value and new value; passwords and keys are masked. Changes to product and price fields are tracked in the same trail.

Production

Vessel, line and cancellation reason on record

ProblemWhich mixing vessel ran for how long? Why are work orders cancelled? Without records, capacity is guesswork.

SolutionWhen starting to mix or fill, the operator selects the vessel or filling line, and start and end times are recorded. Cancellation reasons are chosen from a list, together with who was responsible. The production and capacity report shows utilisation, idle days and cancellation reasons.

Frequently asked questions

How does GMP lot tracking work?

Every raw material and finished lot is its own stock record; lots consumed in production are linked to the work order, and consumption starts with the earliest expiry (FEFO). That lets you trace back from a finished lot and forward from a raw material lot.

Does this replace quality approval?

No. The system keeps records and gates; the release decision belongs to an authorised person and is recorded. Certification scope belongs to the factory’s quality system.

Contact

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Describe your production and the work that is hardest for you in a few sentences. We will get back to you about the pilot, a factory visit or a remote demo.

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