Antihypertensive drugs

The challenge

The solution

The outcome

Requirements

• Define demand and product scope: molecules, strengths, dosage forms, pack sizes, annual volumes, service levels, target markets.
• Verify supplier legitimacy: licenses, GMP/WHO-GMP, GDP, registrations, import/export permits, tax/compliance status.
• Assess product quality: CoA, stability data, impurity profile, bioequivalence where relevant, batch traceability, complaint/recall history.
• Check regulatory fit: local registration support, labeling/artwork compliance, pharmacovigilance obligations, serialization/track-and-trace readiness.
• Review manufacturing capability: capacity, lead times, forecast flexibility, change-control process, dual-site resilience, API sourcing transparency.
• Evaluate commercial terms: pricing, rebates, payment terms, MOQ, freight, incoterms, currency risk, annual price review clauses.
• Validate supply reliability: on-time-in-full performance, safety stock, backorder policy, contingency plans, business continuity.
• Assess logistics and cold-chain needs if applicable: storage conditions, transport validation, warehouse qualification, temperature excursion handling.
• Run financial and ethical due diligence: creditworthiness, sanctions screening, anti-bribery policy, ESG/labor standards, conflict minerals where relevant.
• Confirm quality agreement and governance: responsibilities, deviation/CAPA timelines, audit rights, KPIs, escalation paths, meeting cadence.
• Perform supplier audit and reference checks: site audit, documentation review, customer references, market reputation.
• Onboard with controlled process: master data setup, contract signing, approved vendor listing, trial order, receiving/inspection SOPs, user training.
• Monitor continuously: KPI scorecard, batch defects, lead times, complaints, audit findings, periodic requalification, backup supplier development.

Best practices

• 1. Verify supplier licensing, GMP compliance, and all required regulatory registrations before purchase.
• 2. Source only from authorized manufacturers, wholesalers, or distributors with full traceability.
• 3. Require product quality documentation, including COA, batch records, stability data, and expiry details.
• 4. Validate packaging integrity, labeling accuracy, and serialization/track-and-trace requirements.
• 5. Confirm therapeutic equivalence, dosage strengths, and formulation consistency across all purchased items.
• 6. Review pharmacovigilance and adverse event reporting processes with the supplier and service provider.
• 7. Check for recall readiness, lot traceability, and documented recall procedures.
• 8. Assess storage and transport conditions, including temperature, humidity, and secure handling requirements.
• 9. Use risk-based vendor qualification, including audits, performance history, and financial stability reviews.
• 10. Ensure regulatory and import/export compliance for every market where the products will be distributed or used.
• 11. Negotiate clear SLAs for delivery timelines, fill rates, order accuracy, and issue resolution.
• 12. Confirm anti-counterfeit protections, including secure sourcing, authentication, and chain-of-custody controls.
• 13. Review pricing structures for hidden costs, rebate terms, minimum order quantities, and contract flexibility.
• 14. Align procurement with formulary needs, clinical guidelines, and inventory demand forecasting to avoid shortages or overstock.
• 15. Establish ongoing quality monitoring, KPI reviews, and periodic supplier requalification after purchase.