ANVISA-compliant pharma WMS for Brazil
Brazil's ANVISA regulates pharmaceutical distribution with some of the strictest requirements in LATAM. A WMS for pharma operations in Brazil must cover lot traceability, SNGPC for controlled substances, temperature logging, and NFe integration.
ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's health regulatory agency, and its pharmaceutical distribution requirements are among the most demanding in LATAM. A WMS serving pharma distribution in Brazil must cover multiple specific requirements natively.
Lot traceability to individual unit
ANVISA RDC 430/2020 and subsequent resolutions require traceability to the patient unit in many cases. The WMS must track lot through every movement: receipt → putaway → pick → ship.
SNGPC for controlled substances
For psychotropics, narcotics, and other controlled drugs, ANVISA's SNGPC (Sistema Nacional de Gerenciamento de Produtos Controlados) requires detailed reporting. The WMS must generate SNGPC-compatible reports automatically.
Temperature zone compliance
For thermolabile products, temperature zones (2-8°C, 15-25°C) must be physically separated and continuously monitored. The WMS integrates with dataloggers and logs temperatures per lot.
NFe integration for ICMS
Brazil's ICMS (state-level VAT) requires NFe (Nota Fiscal Eletrônica) for every shipment, with substitution rules by product and state. The WMS must integrate with SEFAZ to issue NFe at shipment.
Recall workflow
If ANVISA issues a recall (product defect, contamination), the WMS must identify in minutes every unit of the affected lot — location, or if shipped, the customer — and freeze remaining stock.
P4 Warehouse has pharmaceutical distribution deployments in Brazil with SEFAZ NFe integration and ANVISA-compliant lot traceability.