Supply Chain Management (SCM) in pharma is the end-to-end control of materials, information, quality, and product flow from API/excipient suppliers to the patient—while maintaining GMP/GDP compliance, preventing counterfeits, and assuring continuous availability.
The next layer is materials management and inventory control: approved vendor lists, incoming verification/testing strategy, quarantine/release status control, and traceability of batch/lot and expiry/retest. Planning functions (forecasting, MRP, safety stock, capacity planning) must consider lead times, single-source vulnerabilities, cold-chain capacity, and regulatory constraints.
Distribution is governed by Good Distribution Practices (GDP)—controls that ensure medicines are stored and transported so they remain within specifications until delivery. WHO highlights that the distribution channel must follow quality assurance to ensure patients receive quality medicines, and provides GDP standards for supply-chain actors. World Health Organization+1 India’s CDSCO also publishes GDP guidance emphasizing protection of the supply chain against NSQ/spurious products across storage and distribution. CDSCO
For temperature-sensitive products, cold chain management is critical: qualified shippers, mapped lanes, calibrated loggers, excursion handling, and stability-based decisions. Security and anti-counterfeit controls increasingly rely on serialization and verification: in the EU, most prescription packs require safety features including a 2D barcode unique identifier and an anti-tampering device (in force since 9 Feb 2019). European Medicines Agency (EMA) In the US, DSCSA “enhanced” electronic traceability requirements moved through a stabilization period that ended Nov 27, 2024, with FDA continuing to manage exemptions/waivers beyond that.
Finally, SCM includes recall readiness, logistics partner qualification, data integrity across systems (ERP/LIMS/serialization repositories), and KPIs (service level, right-first-time release, temperature excursion rate, and supplier defect rate).