Why This Matters in Nigeria
Nigeria’s pharmaceutical industry is one of the most tightly regulated and quality-critical sectors. Whether you manufacture generics in Lagos, distribute vaccines in Abuja, or run a community pharmacy in Port Harcourt, you operate under the watchful eye of NAFDAC.
To thrive, you must:
- Run traceable manufacturing and distribution systems.
- Maintain validated electronic records.
- Be ready for NAFDAC GMP inspections.
- Align with WHO GMP standards and FDA cGMP if you plan to export.
This is where Odoo ERP—when configured and validated properly—can be your compliance backbone. With modules like Inventory, Manufacturing, Quality, and Documents, Odoo supports:
- Lot/serial traceability.
- Expiry date control & FEFO picking.
- In-process quality checkpoints.
- CAPA (Corrective & Preventive Actions).
- Documented audit trails.
And with Newwaves Ecosystem Ltd., you get a partner who not only understands Odoo but also understands regulatory reality. Our 30+ years in IT and our track record as implementing partner for NAFDAC’s Dossier Management System make us uniquely positioned to guide Nigerian pharma businesses.
Regulatory & Business Readiness
Clarify Compliance Scope
- NAFDAC GMP is your anchor—align SOPs and ERP workflows to its requirements on premises, personnel, documentation, production, and QC.
- If you’re eyeing export markets, map overlaps with WHO GMP and FDA cGMP.
- Create a “requirement → ERP control/SOP” table to ensure nothing slips through the cracks.
Form a Cross-Functional Team
- Include QA/QC, Production, Warehouse, Regulatory, Finance, and IT.
- Nominate a Validation Lead to own Computer System Validation (CSV).
Document the URS (User Requirements Specification)
Sample URS lines:
- “System must enforce lot/serial tracking for all APIs and finished goods.” (Odoo Lots & Serials)
- “System must enforce FEFO picking for finished goods.” (Odoo Expiration & FEFO)
- “System must trigger QC checks at defined operations.” (Odoo Quality Control Points)
Decide: Community vs Enterprise
For pharma, Odoo Enterprise is usually best. It includes Quality, MRP, Documents, Studio (for easy customization), mobile apps, and managed hosting. Community can work—but only if you have strong in-house IT resources.
Architecture & Validation Plan
Choose Hosting Strategy
- Odoo.sh or SaaS (Enterprise) for managed infrastructure and smooth upgrades.
- On-prem/cloud IaaS if your validation/control framework requires full environment control.
Design Security & Auditability
- Role-based access.
- Maker-checker approvals for GMP records.
- Audit logs for every critical change.
- Automatic backups with retention policies.
Define CSV Approach
Follow a risk-based validation lifecycle:
- Validation Plan → URS → FS/DS → IQ/OQ/PQ → Traceability Matrix → SOPs.
- If exporting, ensure compliance with 21 CFR Part 11 (e-records/e-signatures).
Module Selection & Core Configuration
Inventory & Traceability
- Enable Lots & Serials for all APIs and finished products.
- Activate Expiry Dates + FEFO removal to ensure correct stock rotation.
Manufacturing (MRP)
- Build Bills of Materials (BOMs) with co-products/by-products.
- Define routings/work centers (granulation, compression, coating, packaging).
- Attach SOPs and work instructions directly into Odoo’s Documents module.
- Schedule preventive maintenance for GMP equipment.
Quality
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Configure Quality Control Points for:
- Incoming raw materials (COA check).
- In-process (moisture, weight, hardness).
- Final release (assay, dissolution).
- Nonconformances trigger Quality Alerts + CAPA workflows.
Warehousing & GDP
- Quarantine zones for unreleased batches.
- Sampling locations and restricted statuses.
- Barcode scanning to minimize mix-ups.
Purchasing & Vendors
- Maintain an Approved Supplier List.
- Track COAs and certificate expiries.
- Score suppliers on compliance and reliability.
Sales & Distribution
- Customer-lot traceability for recall readiness.
- Export documentation built into workflows.
Finance & Costing
- Landed cost calculations on APIs.
- Standard vs actual costing variance analysis.
- Multi-currency for import operations.
Odoo has over 30 in-built modules and these are hand-picked for this topic but not limited to any implementation. Newwaves Ecosystem Ltd. will advise based on the scope of the project in a case where customization is needed.
Data, Integrations & Reports
- Data Migration: Cleanse master data, migrate, and verify products with UoM, control categories, shelf-life parameters; partners (vendors/customers) with compliance docs; opening stock by lot/expiry; open POs/SOs/MOs.
- Run test migrations and reconcile totals before cutover
- Labeling: Configure GS1/lot barcodes, validate scanners.
- Reports: Batch Manufacturing Records (BMRs), Certificates of Analysis (COAs), deviation logs, CAPA dashboards.
- Optional Integrations: LIMS for advanced lab workflows, IoT sensors for environmental monitoring, e-signature gateways, and local payment rails for B2B portals (Paystack/Flutterwave).
Validation & Training
- IQ (Installation Qualification): Controlled install of server specs, versions, users/roles, backups, environment hardening.
- OQ (Operational Qualification): Validate risk-critical functions (lot control, FEFO, QC enforcement).
- PQ (Performance Qualification): Simulate real production batches and log deviations.
- Training & SOPs: Train operators on Odoo screens, finalize SOPs on deviations, QC sampling, and change control.
Cutover & Stabilization
- Go-Live Plan: Freeze master data changes, perform final stock counts by lot/expiry, switch purchasing/production to Odoo
- Post-Go-Live Controls: Daily GMP checks on released vs blocked stock, overdue inspections, CAPA closure rates.
- Audit Prep: Maintain validation files (URS, risk assessments, IQ/OQ/PQ evidence, SOPs, training logs).
What You Gain with Odoo
- Regulatory confidence: GMP-aligned workflows and validated records for NAFDAC.
- Traceability: Instant genealogy and recall readiness.
- Expiry control: Shelf-life monitoring and FEFO discipline.
- Quality by design: QC checkpoints embedded into production.
- Operational visibility: Dashboards for yields, deviations, CAPA progress.
Common Pitfalls (and How to Avoid Them)
- Weak validation → Treat CSV as a deliverables package, not a checkbox.
- Dirty data → Clean master data before migration.
- Skipping quarantine → Always enforce blocked/released stock statuses.
- Over-customizing → Start with standard Odoo, use Studio before coding.
Why Newwaves Ecosystem?
- 30+ Years in IT: A trusted technology partner in Nigeria across industries.
- Proven Odoo Expertise: Certified Odoo Partner with successful ERP rollouts across regulated sectors.
- Regulatory Experience: Official implementing partner of NAFDAC’s Dossier Management System, powered by Odoo.
- Local + Global Insight: We combine Nigerian regulatory understanding with international ERP best practices.
Final Word
Odoo ERP can give Nigerian pharmaceutical manufacturers and distributors a compliant, configurable, and validation-ready system. But success depends on partnering with experts who understand both Odoo technology and NAFDAC compliance.
At Newwaves Ecosystem Ltd., we’ve proven we can deliver—on time, on budget, and in line with global GMP expectations.
Ready to align your pharma business with NAFDAC and global GMP standards? Let’s design, validate, and implement Odoo ERP for your operations.