GMP Engineering

DANISEI ENGINEERING

GMP facility design, clean rooms, validation and production lines.

GMP Facilities

Design, build and commission GMP-compliant pharmaceutical manufacturing facilities to international standards.

Clean Rooms

ISO-classified clean room design and construction — classification studies, particle monitoring and access control.

Validation

IQ, OQ and PQ validation protocols for equipment, utilities and computerized systems — full documentation packages.

HVAC Systems

Pharmaceutical-grade HVAC engineering — controlled environments, monitoring and energy efficiency.

Production Lines

Solid dosage, liquid and sterile manufacturing line design with full equipment integration.

Industrial Consulting

Process optimization, regulatory gap analysis, GMP audits and inspection readiness support.

Standards & Compliance
GMP
International Standards
ISO 9001
Quality Management
ISO 14644
Clean Room Classification
ICH Q10
Pharmaceutical QS
HACCP
Risk-based Compliance