V5 Ultimate
EU GMP · VICH · Medicated feed · Withdrawal periods

Veterinary pharma software with withdrawal periods tied to the batch — VICH, medicated feed, species labelling, live.

Veterinary medicinal products (VMPs), medicated premixes, and medicated feed additive manufacturers running EU GMP Part I/II with VICH overlays. Species-specific labelling, withdrawal-period traceability, carry-over risk in feed lines, and VICH GL-aligned pharmacovigilance built in — not bolted on from a human-pharma platform.

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EU GMP
Parts I & II
VICH GL
Aligned
Medicated feed
Reg 2019/4
Withdrawal
Batch-tied
If any of these sound familiar

You're shopping because human-pharma software doesn't understand species, withdrawal, or feed carry-over.

Withdrawal periods live in a label spec but not on the batch

Medicated feed carry-over risk isn't modelled between production runs

Species-specific labelling drift causes recalls that a linked label engine would prevent

VICH GL pharmacovigilance uses spreadsheets that don't reconcile with QMS deviations

Regulation (EU) 2019/4 for medicated feed changes weren't fully absorbed

Contract manufacturing for MAHs across species multiplies documentation without adding control

What's in the box

Veterinary GMP, built for species.

Withdrawal-period traceability

Withdrawal periods per species per product live on the release record and follow the batch to the customer, distributor and end user.

Medicated feed line control

Regulation (EU) 2019/4 aligned — carry-over risk assessment, cleaning validation between medicated runs, and traceability from active substance to fed animal.

Species-specific labelling

Label master data keyed by species, indication, strength and market. Changes propagate to artwork under change control — no orphan label versions.

VICH GL pharmacovigilance

Adverse event capture, VICH GL 24/29/30/35 alignment, and reconciliation with QMS deviations and complaints in one register.

EU GMP Part I & Part II

Finished VMP (Part I) and active substance (Part II) manufacturing under one QMS — no parallel systems for the API step.

Contract manufacturing for MAHs

Multi-MAH contract manufacturing with per-MAH document sets, per-MAH release, and per-MAH regulatory reporting.

What changes the day this goes live

What changes the day this goes live.

  • Withdrawal period is on the batch record, the label and the shipping doc
  • Feed-line carry-over risk is a live calculation, not a periodic study
  • Species-labelling recalls trend toward zero
  • VICH GL pharmacovigilance and QMS deviations share one register
  • Regulation 2019/4 changes are absorbed structurally, not per-SOP
Regulatory anchor

The frameworks a veterinary QP owns.

EU GMP Parts I & II

Finished veterinary medicinal products (Part I) and active substances (Part II) under one QMS with QP release and PSF equivalent for VMPs.

Regulation (EU) 2019/6 & 2019/4

Veterinary Medicinal Products Regulation and Medicated Feed Regulation — species scope, carry-over, cascade prescribing evidence, and Union Product Database data support.

VICH Guidelines

International Cooperation on Harmonisation of Technical Requirements for Veterinary Medicinal Products — GL 24 / 29 / 30 / 35 pharmacovigilance and quality guidelines aligned.

21 CFR Part 11

§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.

EU GMP Annex 11

Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.

GAMP 5 Second Edition

Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.

Questions buyers actually ask

Veterinary pharma software, answered.

Does V5 handle medicated feed under EU 2019/4?

Yes. Medicated feed line control includes carry-over risk assessment, cleaning validation between medicated runs, and traceability from active substance to fed animal per Regulation (EU) 2019/4.

How are withdrawal periods managed?

Withdrawal periods per species per product live on the release record and follow the batch to the customer and end user. Label, shipping doc and batch all reconcile to the same figure.

Can we run multi-MAH contract manufacturing?

Yes. Per-MAH document sets, per-MAH release workflow and per-MAH regulatory reporting are native — one physical site can run many MAH clients cleanly.

Does this cover VICH GL pharmacovigilance?

Yes. Adverse event capture, VICH GL 24/29/30/35 alignment, and reconciliation with QMS deviations and complaints in one register — no parallel PV spreadsheet.

Run VMPs on software that understands species.

Free trial. Real withdrawal, real feed control, real VICH.