Production
Sequencing that blocks
Sequencing rules block an unsafe production order before the batch starts, rather than warning about it after; flush and cleanout record themselves as evidence.
IndustriesVeterinary
• Veterinary
One unbroken trace from premix to treated animal
Sequencing and flush rules are enforced before a batch starts. Prescription limits are hard boundaries. One trace runs from premix to the treated animal.
Supported frameworks, not certifications. Regulatory updates included.
Trace every ingredient to its use.
- 01Supplier lot
- 02Premix batch
- 03Species & market
20 configured controlsRegulation (EU) 2025/2091 · Regulation (EU) 2025/2154 / VICH GL60 · Regulation (EU) 2019/6
One controlled record
Why now
Veterinary GMP is
its own regulation now.
EudraLex Volume 4 used to cover human and veterinary manufacturing together. Since 16 July 2026, veterinary practice has its own implementing regulations.
- Guidance became law
The requirements stay close to human GMP, but they are now binding, and inspections follow.
- Medicated feed is a second regime
Carry-over, prescription validity, treatment duration and the ban on antimicrobial prophylaxis are hard limits.
- Schedules break these first
Inspectors test them early, because production plans often cross them.
What is tailored
Blocked before it starts.
Followed to the animal.
Where the Veterinary pack changes how the core behaves.
Quality
Withdrawal, computed
Withdrawal period computes and carries to the treated animal automatically, including cascade defaults under Article 115.
CAPA
Signals on the clock
Continuous signal management submits suspected adverse events on the 30-day clock, with the qualified person named on the file.
Built for veterinary
Unsafe orders never start.
And the trace reaches the animal.
These features switch on with the veterinary pack, on the same record as your production and quality work.
01 / Production · Sequencing and flush
The batch waits for its flush.
Start checks block non-target feed scheduled straight after a medicated batch. The flush and cleanout record themselves as evidence before the next batch opens.
- 01Blocked, not warned.
Sequencing rules check the order before the batch starts, and an unsafe one cannot open.
- 02The flush is the evidence.
Each flush and cleanout step records its time and who did it, and the flush batch is held against the run it protects.
- 03Carry-over, within limits.
Carry-over into non-target feed is checked against the limits in Annexes I and III before the next batch opens.
02 / Inventory · Premix to treated animal
One trace, from premix to the treated animal.
Each premix lot links forward to the medicated feed, the prescription, the holding and the animals treated. Recall reach shows what is under review, so only the affected stock is held.
- 01One continuous trace.
Premix, medicated feed, prescription, holding and animal are held as one record, not five registers.
- 02Hold only what is affected.
Recall reach lists the batch to hold, the customers to notify and the stock to quarantine, and nothing else stops.
- 03Answer in one search.
A quality question about a lot opens with its inputs and deliveries in one history, instead of a file hunt.
03 / QMS · Adverse events
Suspected adverse events, on the clock.
Each report is logged with its reporting clock and owner from intake. Signal management runs continuously, and the qualified person is named on the file.
- 01The clock starts at intake.
A suspected adverse event starts its reporting clock the moment it is logged, with an owner and a due date.
- 02The right clock, by jurisdiction.
30 days to the Union database, or 3 and 15 working days for the US reports that apply, set by the report type.
- 03A named qualified person.
The pharmacovigilance system master file names the qualified person, and each report carries the name.
04 / Quality · Withdrawal periods
Withdrawal follows the animal.
The withdrawal period is computed from the product’s authorised periods and carried to the treated animal. Off-label use under the cascade applies the Article 115 minimums automatically.
- 01Computed, not looked up.
Withdrawal is worked out from the product’s authorised periods for each species and produce, with the rule shown.
- 02Cascade minimums applied.
Off-label use applies Article 115: one and a half times the longest authorised period, or the statutory minimum, such as 10 days for eggs.
- 03Carried to the treated group.
The result is recorded against the treated group and travels with the trace, so it is never retyped.
Withdrawal, retention, reporting
The numbers inspectors check
are computed for you.
Cascade minimums are applied when a product is used off-label. Retention and reporting run on their own clocks.
Article 115 cascade
Withdrawal periods the system computes
Statutory minimums, not judgement. The pack applies them and records the result against the treated group.1.5×
The longest authorised withdrawal period
Where one exists28days
Meat and offal
Product not authorised for food-producing animals7days
Milk
10days
Eggs
500degree-days
Aquatic species
1day
Zero-withdrawal product, different taxonomic family
25 degree-days for aquatic species
Retention
Three retention clocks, one plant
The record classes look alike. The obligations do not.5years
US adverse event records
21 CFR 514.802years
Veterinary Feed Directive records
Veterinarians, distributors and clients1year
Medicated feed production, assay, distribution and drug receipt
Part 225
Reporting
Reporting clocks the system runs
30days
Any suspected adverse event, to the Union pharmacovigilance database
European Union3working days
Product or manufacturing defect report
US · 21 CFR 514.8015working days
Serious and unexpected adverse drug experience
US · 21 CFR 514.806months
Periodic drug experience reports, for 2 years, then annually
US · 21 CFR 514.80
Controls
20 controls.
7 standards.
Every control below runs on the Compliance Engine. The same record carries the evidence across the plant.
Also mappedRegulation (EU) 2025/2154 / VICH GL60
11 controls shown for EU 2025/2091
Append-only, hash-chained audit trail capturing old value, new value, author, time and reason
Sequencing rules enforced before the batch starts, blocking an unsafe production order rather than warning about it
Flush and cleanout recorded as evidence, with the flush batch held against the run it protects
Carry-over limits applied to non-target feed per Annexes I and III
Homogeneous dispersion verification with assay results attached to the batch
Assay sampling scheduled against the calendar year requirement, three representative samples per drug with one from the first batch
Master Record File and production records with unique batch identification and full tracing
Labelling proofread against the Master Record File, dated and attributed
Role-based access control, down to the individual field
Segregation of duties enforced in the system, maker is never checker
Retention clocks by record class, five years, two years and one year, applied automatically
Regulatory change
We watch the rules.
You do not have to.
The Compliance Engine tracks the rules that apply to you, works out what a change touches, updates the system and re-validates before release. You file no change request.
- • applied
US Veterinary Feed Directive takes full effect
Medically important antimicrobials in feed moved under a licensed veterinarian’s oversight, which the pack models as prescription limits.
- • applied
EU veterinary medicines and medicated feed rules apply
Regulations 2019/6 and 2019/4 became applicable, including the ban on routine antimicrobial prophylaxis and the medicated feed carry-over rules.
- • applied
Medicated feed regime built alongside the GMP split
Carry-over limits, prescription validity and the antimicrobial prophylaxis prohibition shipped as hard limits in the same release that split veterinary GMP from human GMP.
- • applied
Veterinary GMP split from human GMP
EudraLex Volume 4 no longer covers human and veterinary manufacturing together. Two Commission Implementing Regulations now carry veterinary manufacturing practice and veterinary active substance practice in their own right — guidance became binding regulation.
Validation readiness
Controls built in,
not configured on top.
Validation packs
Available on the Dedicated tier, mapped to your workflows. URS, IQ, OQ, PQ, RTM and GAMP 5.
ISO 27001
Certification in progress. Encryption, access control and backups are described on Security & Trust.
Readiness, scored
The Compliance Engine scores inspection readiness continuously, with guidance on each open gap.
Make it your workflow
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to walk through?
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