authorized batch
[/ˈɔːθəraɪzd bætʃ/]
nounpl: authorized batches
lote autorizado
1. A group or quantity of items (products, documents, or goods) that has been officially approved or permitted by an authorized person or entity for production, distribution, or use
The pharmaceutical company released an authorized batch of vaccines after passing all regulatory inspections.
A empresa farmacêutica liberou um lote autorizado de vacinas após passar por todas as inspeções regulatórias.
2. In manufacturing and quality control, a set quantity of items produced under controlled conditions and approved for commercial release
Each authorized batch must include a certificate of analysis and compliance documentation.
Cada lote autorizado deve incluir um certificado de análise e documentação de conformidade.
This term is predominantly used in technical, manufacturing, and regulatory contexts in both English-speaking and Portuguese-speaking countries. It reflects quality assurance practices that are critical in pharmaceuticals, food production, and industrial manufacturing. In Brazil, regulatory standards are enforced by ANVISA (Agência Nacional de Vigilância Sanitária), making authorized batch documentation essential for market compliance.
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