Pergunta de entrevista da empresa Mankind Pharma

How do you ensure that the equipment you procure for injectable plants meets regulatory requirements like USFDA, EU-GMP, or WHO-GMP

Resposta da entrevista

Sigiloso

27 de abr. de 2025

Whenever I procure any equipment for injectable formulation, I first ensure that a proper URS is created along with inputs from QA, Engineering, and Production teams. Before finalizing the vendor, I check that the equipment complies with cGMP standards, USFDA/EU-GMP requirements, and relevant guidelines like ASME BPE for sterile equipment. During procurement, I ask for DQ (Design Qualification), FAT (Factory Acceptance Test) documents, and material traceability certificates (MOC Certificates - SS316L for product contact parts). Only after reviewing documents and involving QA validation teams do I finalize the purchase. During installation, IQ, OQ, PQ are coordinated with Engineering and Validation teams to ensure full compliance before commercial production starts