Drugs affecting the gastrointestinal system

The challenge

The solution

The outcome

Requirements

• Define demand: product list, volumes, dosage forms, target markets, service levels.
• Set sourcing goals: quality, cost, continuity, lead time, regulatory compliance, risk tolerance.
• Screen suppliers: GMP certification, licenses, manufacturing capacity, track record, financial stability.
• Verify product scope: GI therapeutic classes, specifications, strengths, pack sizes, cold-chain or special handling needs.
• Check quality systems: audits, QA release process, batch traceability, deviation/CAPA management, complaint handling.
• Confirm regulatory readiness: dossier support, market authorizations, pharmacovigilance, serialization, labeling compliance.
• Assess supply resilience: dual sourcing, raw material security, buffer stock, disaster recovery, on-time delivery history.
• Evaluate commercial terms: pricing, rebates, MOQ, payment terms, Incoterms, freight, return/recall terms.
• Review logistics capability: warehousing, temperature control, customs clearance, distribution footprint.
• Validate documentation: CoA, MSDS where relevant, stability data, certificates, product registration files.
• Run risk checks: sanctions, ethics, anti-bribery, ESG, counterfeit prevention, cybersecurity if digital integration exists.
• Perform due diligence audit: site visit or remote audit, sample testing, reference checks.
• Select supplier: scorecard against quality, cost, service, compliance, and risk criteria.
• Contract carefully: quality agreement, SLAs, penalties, change-control, forecast commitments, termination clauses.
• Onboard operationally: master data setup, EDI/order process, contacts, escalation paths, training.
• Pilot launch: first-batch validation, test ordering, shipment tracking, invoice matching.
• Monitor continuously: KPIs for fill rate, OTIF, defects, deviations, lead time, cost, and CAPA closure.
• Review periodically: business review, re-audit schedule, contingency plans, and alternate supplier qualification.

Best practices

• 1. Verify supplier licensing, GDP/GMP compliance, and regulatory registrations.
• 2. Require full product traceability, including batch/lot numbers and expiry dates.
• 3. Confirm product authenticity with anti-counterfeit and serialization controls.
• 4. Review clinical indications, formulations, strengths, and dosage forms against demand.
• 5. Assess storage, handling, and cold-chain requirements before purchase.
• 6. Validate quality documentation: COA, MSDS/SDS, and stability data.
• 7. Check recall history, adverse event reporting, and pharmacovigilance processes.
• 8. Negotiate clear service-level agreements for supply continuity and lead times.
• 9. Audit packaging integrity, labeling accuracy, and language/regional compliance.
• 10. Establish approved vendor lists and qualification procedures for all suppliers.
• 11. Compare total cost of ownership, not just unit price, including logistics and wastage.
• 12. Confirm inventory management support for shelf-life monitoring and stock rotation.
• 13. Ensure contract terms cover returns, shortages, substitutions, and emergency supply.
• 14. Align purchases with formulary, therapeutic guidelines, and internal clinical governance.
• 15. Conduct periodic performance reviews of supplier quality, delivery, and compliance.