Pharmaceutical

The facts

• Drug shortages and supply disruptions have reached record levels in recent years, directly impacting patients and increasing pressure from health authorities.
• Dependence on a limited number of manufacturing sites—often located in Asia—makes the entire supply chain vulnerable, particularly for critical active pharmaceutical ingredients (APIs).
• Demand forecasting and inventory management systems are often insufficient to identify supply risks before they become actual shortages.

Les préconisations

• Implement an early warning system to detect supply risks by product and market.
• Diversify sources of active pharmaceutical ingredients and strengthen strategic inventory for critical molecules.
• Establish an S&OP process that incorporates regulatory constraints and early upstream warning signals.

The facts

• Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) impose strict requirements regarding storage conditions, transportation, and traceability at every stage of the supply chain.
• Regulatory inspections (ANSM, EMA, FDA) are increasing, and non-compliances can lead to product recalls or the suspension of marketing authorizations.
• The expansion of distribution networks (3PL providers, new markets) makes maintaining compliance increasingly complex to manage.

Les préconisations

• Structure supply chain quality processes to ensure GDP compliance at every stage, including with logistics service providers.
• Implement regular supplier and 3PL audits with documented qualification criteria.

The facts

• The growth of biotherapies and vaccines is driving increasingly stringent cold chain requirements (2–8°C, -20°C, and even -80°C) across global supply chains.
• Any cold chain breach can render a batch unusable, with major financial and regulatory consequences.
• The qualification and monitoring of temperature-controlled equipment, vehicles, and warehouses remain a daily operational challenge.

Les préconisations

• Deploy real-time temperature monitoring systems across the entire supply chain.
• Train operational teams and service providers on the specific requirements of pharmaceutical cold chain management.
• Integrate temperature-related constraints into flow planning and the selection of logistics providers.

The facts

• The European Falsified Medicines Directive (FMD) requires serialization and verification of every medicine pack at the point of dispensing.
• The operational implementation of serialization remains a challenge for many manufacturers, particularly on packaging lines and within information systems.
• Non-EU markets impose their own traceability requirements (Russia, Saudi Arabia, Brazil), making management increasingly complex for international players.

Les préconisations

• Audit and optimize serialization processes on packaging lines to reduce rejection rates.
• Structure traceability data management to simultaneously meet the requirements of multiple regulatory markets.

The facts

• Pricing pressure on reimbursed medicines reduces the available margins to absorb logistics inefficiencies.
• The costs of poor quality (recalls, product destruction, non-compliances) remain poorly measured and underestimated in most pharmaceutical organizations.
• Planning systems (ERP, APS) are often underutilized, leaving significant performance improvements untapped.

Les préconisations

• Identify and quantify the hidden costs of supply chain underperformance to prioritize improvement initiatives.
• Optimize the use of existing planning tools before considering new system investments.
• Deploy DDMRP to decouple flows from variability and reduce tied-up inventory without impacting service levels.