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Every machine manufactured by GentlemanPharmed is designed, fabricated, and validated in strict conformity with international cGMP, WHO-GMP, and ISO standards.
ISO 9001:2015 Quality Management System
TUV / International Quality Certification
Certified design, precision manufacturing, assembly, testing, and commissioning processes for pharmaceutical and packaging machinery.
WHO-GMP Compliant Manufacturing Standard
World Health Organization GMP Guidelines
Equipment design adheres strictly to WHO Technical Report Series guidelines for oral solid dosage and sterile parenteral manufacturing equipment.
CE Conformity (Machinery Directive 2006/42/EC)
European Conformity Notified Body
Conforms to European health, safety, and environmental protection legislation including Low Voltage Directive (LVD) and EMC compliance.
USFDA 21 CFR Part 11 & GAMP 5
International Society for Pharmaceutical Engineering (ISPE)
Automation software and HMI controls validated for electronic records, electronic signatures, and audit trail data integrity.
Quality is not an afterthought — it is engineered into every component from initial metallurgical sourcing to final site acceptance testing.
Scope
Design, manufacture, installation and after-sales service of pharmaceutical processing and packaging machinery at the Kolkata manufacturing site. Bought-out components are controlled through supplier qualification but are not themselves covered by the certificate, and the Dhaka service office is outside the certified scope.
Third-party certification of the quality management system under which every machine in the range is designed, built and tested. It certifies the process, not the performance of an individual machine.
Scope
Equipment design, materials of construction and handover documentation support a licensed Indian manufacturer in meeting revised Schedule M. The regulation binds the licence holder; this is a supplier statement, not a licence, inspection outcome or certificate.
India's revised Good Manufacturing Practice requirements for pharmaceutical manufacturers, covering premises, equipment qualification, cleaning and documentation.
Need our certification documents for your regulatory submission? Contact us and we'll send them over.