Demo Novalife Pharma: a regulated manufacturing day

Demo Novalife Pharma manufactures sterile injectables, tablets, and diagnostic kits in India and the UAE, then sells through distributors and hospitals across the Gulf, East Africa, and Europe. It must trace every raw-material lot to finished batch, quarantine unreleased stock, control expiry and temperature, manage quality deviations, calculate rebates, and prove the financial effect of a recall. OSERP connects formula, production order, batch genealogy, quality inspection, warehouse, shipment, invoice, rebate, and general ledger.

1. Configure legal entities, plants, and controlled warehouses

Create a company per jurisdiction, then plants, clean rooms, packaging lines, quality labs, finished-goods warehouses, quarantine zones, cold rooms, and destruction locations. Configure functional and reporting currencies, tax profiles, fiscal calendars, numbering series, UoM conversions, quality roles, approval limits, and period locks.

Setup field	Demo value	Impact
Company	Novalife UAE Manufacturing LLC	Statutory ledger
Plant	Abu Dhabi Sterile Plant	Production ownership
Warehouse	AD-FG-COLD-01	Released finished goods
Quarantine	AD-QA-HOLD-01	Prevents unauthorised use
Product family	Sterile injectable	Formula and controls
Currency	AED	Local books
Group currency	USD	Consolidation
Quality system	GMP-QMS-01	Inspection and release policy

Users are scoped by company, plant, warehouse, and quality role. A production operator can report output but cannot release a batch. A warehouse clerk can pick released stock but cannot move a quarantined lot without a quality disposition.

2. Maintain items, formulas, and controlled specifications

Item masters store product code, generic name, strength, dosage form, pack size, UoM, storage condition, shelf life, tax class, serialisation rule, and status. Raw materials store supplier, specification, lot, expiry, retest date, allergen or hazard, and approved-vendor list. Formula versions store active ingredient, excipients, process loss, yield, equipment, instructions, effective dates, and approver.

Example: NV-CEF-1G sterile vial has a 24-month shelf life, 2–8 °C storage, serialised cartons, and a 98.5% expected yield. A formula change creates version 3 with effective date and change-control reference. Existing production orders retain the version used; they must not silently inherit the new formula.

3. Procure and receive raw materials under quarantine

Purchase requests contain plant, formula, material, specification, quantity, required date, approved supplier, budget, and quality requirement. Purchase orders preserve currency, tax, delivery terms, test certificate requirement, and batch/expiry constraints. Goods receipts capture supplier lot, manufacturer lot, quantity, UoM, expiry, retest date, temperature, container seal, and inspection status.

All incoming materials enter Quarantine until sample results and quality approval are complete. A rejected receipt records reason, evidence, supplier notice, and disposition. Imported API material priced in EUR retains freight, insurance, duty, port charges, and landed cost allocated to the accepted lot.

4. Plan and execute a batch production order

The production order stores product, formula version, plant, line, batch number, planned quantity, start/end, campaign, yield target, operator, and status. Consumption rows record raw lot, issued quantity, actual quantity, UoM, and variance. Output rows record finished batch, quantity, pack, serial range, yield, and location.

Status path: Planned → Released → Dispensing → In process → Packed → QA hold → Released, with Cancelled, Rejected, and Destroyed controlled by reason and approval. A batch cannot be released until required in-process checks, reconciliation, environmental readings, and quality results exist.

Batch field	Demo value	Why it matters
Batch	NV-CF-260917-01	Genealogy and recall key
Formula version	NV-CEF-1G v3	Reproducible recipe
Planned output	10,000 vials	Capacity and yield
Actual output	9,850 vials	Variance and cost
Process loss	1.5%	Within tolerance or exception
QA status	Released	Sale eligibility

An abnormal yield variance opens a deviation and blocks release. The variance journal identifies normal loss, abnormal loss, scrap, or rework according to policy.

5. Run quality inspections and release decisions

Inspection plans store product, stage, characteristic, specification, method, sample size, instrument, unit, frequency, and acceptance range. Results store batch, sample, analyst, timestamp, value, pass/fail, attachment, and reviewer. Environmental monitoring stores room, temperature, humidity, pressure, alarm, and corrective action.

Quality disposition stores batch, decision, reason, deviation, CAPA, approver, date, and effective status. Released permits picking; Conditional release requires an expiry and documented risk; Rejected moves to quarantine or destruction. Quality users cannot edit a result after approval; corrections are versioned with reason.

6. Pack, serialise, and manage expiry

Packaging orders store pack size, artwork version, label language, serialisation rule, aggregation hierarchy, and line clearance. Serial numbers link unit, carton, case, pallet, batch, expiry, and customer shipment. Expiry policy determines FEFO allocation and minimum remaining shelf life by customer or country.

A label change is a controlled version with approval and effective date. A serialisation exception records missing or duplicate serial, scanner, operator, correction, and disposition. Expired or short-dated stock is blocked from sale and routed to return, rework, donation, or destruction with witness evidence.

7. Sell to distributors and hospitals with contract pricing

Customer profiles store legal identity, licence, country, tax registration, credit limit, currency, cold-chain capability, and status. Sales orders store product, batch or shelf-life requirement, quantity, price, discount, rebate programme, tax, delivery temperature, Incoterm, and requested date. Allocation reserves released batches by FEFO and certification.

Distributor contracts store price list, volume tiers, free goods, rebate rate, returns policy, payment terms, territory, and effective dates. A hospital order can require serial capture, temperature logger, and certificate of analysis. A sale to a customer with an expired licence is blocked.

8. Ship cold-chain products and prove custody

Shipment headers store order, carrier, vehicle, container, seal, origin, destination, Incoterm, insurance, currency, and status. Detail rows store batch, serial or pallet, quantity, expiry, temperature range, logger, dispatch reading, arrival reading, and proof of delivery.

A temperature excursion creates a hold against the shipment and affected batch. The quality team decides release, return, or destruction. Partial delivery reduces open quantity without changing the original sales order. Export documents include invoice, packing list, certificate of analysis, certificate of origin, and regulatory permit.

9. Invoice, collect, and calculate rebates

Invoices separate product, freight, tax, discount, free goods, and rebate accrual. The invoice stores customer, order, batch, serial or pallet, currency, rate, due date, tax code, and revenue account. Receipts store bank, value date, currency, reference, allocation, fees, and unapplied balance; duplicate references are rejected idempotently.

Rebate statements store distributor, programme, period, eligible sales, returns, tier, rate, amount, evidence, approval, and settlement. A rebate is accrued from approved sales and adjusted for returns or credit notes. Staff must not reduce revenue manually to hide a future rebate liability.

10. Manage returns, recalls, deviations, and CAPA

Returns store customer, invoice, batch, serial, quantity, reason, temperature evidence, condition, credit decision, and disposition. A recall record stores affected product, batch or serial range, risk, regulator notice, customers, quantities shipped, quantities recovered, communication, and closure approval.

A deviation links event, batch, equipment, operator, root cause, impact assessment, corrective action, preventive action, owner, due date, and verification. Recall cost separates transport, replacement, destruction, customer credit, investigation, and regulatory expense. Original invoices and batch history remain immutable.

11. Close regulated operations and group books

Close reconciles raw-material lots, batch output, QA holds, released and expired stock, serial ranges, cold-chain shipments, returns, rebates, customer receivables, supplier bills, CAPA costs, payroll, assets, tax, FX, and intercompany transfers. The stock ledger must agree to physical batch and serial counts by warehouse and status.

An India purchase in EUR, UAE production in AED, and European sale in USD retain transaction rate, source, timestamp, realised FX, and revaluation status. Period lock prevents backdated batch release, shipment, or destruction. Corrections reference original records, quality approval, and accounting policy.

KPI	Before OSERP discipline	After OSERP discipline	Improvement
Batch genealogy completeness	89%	99.9%	+10.9 points
QA release cycle	7 days	2 days	71% faster
Expiry write-off	4.8%	1.3%	73% lower
Recall trace time	36 hours	2 hours	94% faster
Distributor rebate close	19 days	5 days	74% faster
Month-end regulated close	18 days	7 days	61% faster

Practice challenge

Create Novalife UAE, a formula and version, an imported raw-material receipt, quarantine inspection, production batch, yield variance, QA release, serialised packing, FEFO allocation, cold-chain shipment, distributor invoice, rebate statement, return, recall, CAPA, multi-currency settlement, and period close. For every field, explain its type, length or precision, source, permission, validation, accounting impact, tax result, API identifier, exception path, and audit event.

Related: Manufacturing lab, Inventory field guide, Sales order field guide, AR Invoice field guide, AP Invoice field guide, GL mapping guide, Multi-currency lab, and API cookbook.