Recipe Formulation System

Recipe Formulation System – Digital Accuracy & Compliance with V5

This page is part of the SG Systems Global product glossary and solution library.

Updated October 2025 • Batching, Ingredient Kitting, Lot Verification • MES/QMS/WMS • Pharmaceuticals, Supplements, Food, Cosmetics

Recipe Formulation System software should not be a PDF vault. It must execute recipes: enforce targets at the scale, verify lots with scanners, keep operators on schedule, and generate a tamper‑evident Electronic Batch Record (eBMR) as work happens. SG Systems Global’s V5 Formula Control and Ingredient Management modules hard‑gate batching and kitting so every gram and every decision is traceable.

What Is a Recipe Formulation System?

A true system is an execution layer: it leads operators through step‑by‑step digital work instructions, applies weighing & dispensing tolerances, performs lot and status checks, captures signatures, and prevents deviation. It is the opposite of “print and pray.”

Batching & Ingredient Kitting—Operators Can’t Get It Wrong

V5 pairs the right component, lot, container, and weight at the right time. Kitting is sequenced with Next prompts and pre‑staging (minors/micros first) to compress walk time. Every weighment writes: net, tolerance result, operator, timestamp, and scale ID—rolled into batch genealogy.

“If it isn’t scanned, weighed in tolerance, and signed, it doesn’t pass.” That’s how you kill rework, recalls, and the quiet margin drain of giveaway.

Accuracy by Design: Scales, Tolerances, and Data Integrity

V5 works with existing Stevens/Mettler Toledo terminals and modern load‑cell interfaces. Tolerances apply per ingredient and step; gravimetric weighing locks the UI until net is in range. Out‑of‑tolerance attempts create a Deviation; repeat hits can auto‑launch CAPA. Every entry follows ALCOA+ so records are attributable, legible, contemporaneous, original, and accurate.

Lot Verification, Hold/Release & Allergen Controls

Before a gram is weighed, V5 validates the lot’s release status, checks FEFO/FIFO, and enforces allergen segregation. Fails block progression and get logged. Result: live, enforced traceability—not a reconstruction later.

Keep Operators on Schedule—No Whiteboards

Finite‑capacity scheduling dispatches the right work to the right station and flags blockers (materials not staged, equipment out of calibration, line not cleared). Operators see a clean queue with time expectations and visible OTIF impact. Supervisors see bottlenecks and OEE risks in time to act.

From Execution to Evidence: eBMR, BMR, and MMR

As batching and kitting proceed, the system compiles a complete record: recipe version, parameters, signatures, weighments, scale IDs, genealogy, and yield variance. The final eBMR references the governing MMR/MBR, speeding QA review and release.

Compliance Foundations Built‑In

V5 enforces controls across 21 CFR 210/211 (Pharma), Part 111 (Supplements), Part 11 (e‑records/signatures), HACCP/ISO 22000, BRCGS/SQF (Food), and 21 CFR 820 & ISO 13485 (Medical Devices), plus EU Annex 11, GAMP 5, and CFIA SFCR.

Execution Flow: From ERP to Line and Back

Orders, BOMs, and routings drop from ERP into the V5 Solution Suite. V5 returns consumption, yield, CoA links, and genealogy in real time so ERP and inventory remain synced.

ISA‑88 Discipline—Without Bloat

V5 follows the practical spirit of ISA‑88: consistent phases, equipment modules, and parameterization across lines and sites. You get standardization with local flexibility.

Operator Experience: Fast, Clear, Enforced

• Clear “what’s next” prompts prevent sequence errors (poka‑yoke).
• Scan‑to‑verify every lot and container; dual verification for critical steps.
• Live scale feedback with color‑coded tolerance bands.
• Automatic line clearance and calibration checks before first weighment.
• E‑signatures per action (Part 11) with role‑based permissions (UAM).

Allergen, Label & Identity Protections

Before weighing, V5 verifies identity, enforces allergen segregation, and validates label checks. Controls travel with the batch through fill, label, and packout to prevent wrong‑label incidents.

Data That Pays for Itself

Real‑time capture enables SPC and variation analysis, so you correct drift before it becomes waste. Measure first‑pass yield, track COPQ, and validate improvements with hard numbers.

FAQs – Recipe Formulation & V5

Does V5 work with our existing scales and printers?
Yes. Keep Stevens/Mettler terminals and printers; gain hard‑gating, full traceability, and electronic records.

Can we enforce different tolerances per ingredient?
Yes. Targets/windows are per step and per material. Critical actives can require witness checks or supervisor overrides.

How do potency adjustments work?
When an API assay deviates, V5 computes a revised target (within validated limits) and records the calculation and approvals under your SOP.

Can we replicate recipes globally?
Yes. Use versioned recipes with site‑specific parameters and governance via Change Control and Quality Agreements.

How do auditors review?
Through the eBMR: complete audit trail, signatures, weighments, scans, deviations, CAPAs, and attachments (CoAs, photos), all searchable/exportable.

Glossary Links for Deeper Reading

• Recipe Formulation • Recipe Management • Recipe Versioning
• Batch Weighing • Micro‑Ingredient Dosing • Tare Weight
• Barcode Validation • Lot Traceability • Rework Traceability
• Electronic Batch Record (eBMR) • BMR • MMR
• 21 CFR Part 11 • GMP • HACCP • FSMA 204 KDE
• ISA‑88 • ISA‑95

Related V5 Product Pages

• V5 Formula Control Scale System – enforce targets, eliminate giveaway, prove compliance.
• Ingredient Management System – staging, kitting, FEFO/FIFO, and lot controls.
• Traceability & Compliance – end‑to‑end genealogy, recall readiness, evidence on demand.
• V5 Solution Overview – MES/QMS/WMS with ERP connectivity.

Ready to enforce accuracy, accountability, and audit‑ready traceability? Contact SG Systems for a hands‑on demo of V5 Recipe Formulation.