GMP certification, validation of DQ, IQ, OQ, PQ

RUSNANOCLIMATE, by qualified engineers from Russia and Germany performs GMP audit of projects, construction works, operating companies, clean rooms. Our GMP experts assess and documented proof of compliance with design documentation requirements of state standards, GMP, and in case of inconsistencies - make a list of comments and recommendations. As experts in field of construction buildings, engineering systems, clean rooms, RUSNANOCLIMATE engineers conduct audit of quality mounting technology, laboratory equipment, clean room systems, engineering systems. Particular attention is usually paid to automation systems, air preparation.

RUSNANOCLIMATE offers to Customers complex service of GMP Consulting, which includes assessment of operating medical-pharmaceutical companies in Russia and CIS for GMP compliance, estimate of investment costs (when chief engineers of projects, GMP experts, technologists and economists work together on technical and economic analysis of reconstruction project, a new construction - all activities required to transition company on GMP).

Our company acts as general contractor, independent GMP expert, technical supervision of design, construction and installation work on health care, pharmaceutical, microelectronics objects, allowing to customers minimize risks in terms of compliance projects by Russian and international standards, GMP, ensuring deadlines and quality.

RUSNANOCLIMATE performs complex of services for validation of pharmaceutical companies, clean rooms. Checking of design decisions, constructed buildings, clean complexes, construction works, production technology, laboratory equipment is responsibility of our company. We carry full range complex of services for validation at any stage of implementation investment projects.
 

GMP certification

By 2014, national producers of medicines must go to European standard "Good Manufacturing Practice for Medicinal Products (GMP)", in which devoted special place purity of room and air.

For obtaining GMP certificate pharmaceutical company must complete verification of GMP conformity, for that invited authorized representatives which find out and enforce rules and standards of quality assurance and quality control in the enterprise.

For certification RUSNANOCLIMATE working with ICO (INTERNATIONAL CERTIFICATION ORGANIZATION) - independent certification body for compliance with international and national standards.

Service for constructed buildings, clean rooms, engineering

RUSNANOCLIMATE has service system maintenance of buildings, clean room complexes, engineering "from a single source." As part of service objects, investors transmit to RUSNANOCLIMATE operation maintenance of buildings and structures "turnkey".

Provided on work during design phase, our engineers are ready offer complex automation and dispatching buildings, which allows minimize operating costs, improve quality and timing of service work in finished buildings, maintain health of engineering systems and clean rooms at high level. We are ready around the clock monitor engineering systems, quickly eliminating the faults as they arise.