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This website is under development. Content, specifications and figures shown are placeholders for demonstration only — they are not accurate or genuine company information.
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.
### Our Uncompromising Quality Assurance Commitment Quality is not an afterthought — it is engineered into every component from initial metallurgical sourcing to final site acceptance testing. * **Metallurgical Verification:** 100% of stainless steel raw materials (AISI 316L and AISI 304) undergo spectrometer chemical composition verification and are delivered with mill test certificates (MTC 3.1). * **Surface Roughness Compliance:** Contact surfaces are mechanical and electro-chemically polished to a certified roughness of Ra ≤ 0.4 µm (16 micro-inch), verified with calibrated surface profilometers. * **GAMP 5 & 21 CFR Part 11 Software:** Control architectures incorporate multi-tier access security, electronic signatures, time-stamped audit trails, and automatic data archiving to ensure complete data integrity.
Need our certification documents for your regulatory submission? Contact us and we'll send them over.