Over the years of experience Pharma Group Baltic has successfully accomplished a number of large, medium and small-scale projects. We have recommendation letters from our largest Clients:
JSC Takeda Yaroslavl (Nycomed), Yaroslavl, Russia, 2012-2013
Recommendation letter, pdf, 2Mb
Berlin-Chemie AG Menarini, Kaluga, Russia, 2013
Recommendation letter, pdf, 320Kb
JSC Teva, Yaroslavl, Russia, 2014-2015
Recommendation letter, pdf, 900Kb
Realized Projects:
OlainFarm, Solid dosage forms and API production,
Rīga region, Latvia
Conduction of Computer Validation / implementation of GAMP 5 Life-cycle for two computerized control systems in the API production area.
RGCC, Research Genetics Cancer Center, Sterile and oral dosage cytostatics production, Florina, Greece
Conceptual and basic design. GMP consulting, development of URS, conducting FATs, qualification/validation. Design, supply, installation, programming and start-up of electronic GMP-monitoring system for clean rooms and major equipment.
Takeda, Finished pharmaceuticals production, Põlva, Estonia
Conceptual Design of facility reconstruction. Validation Master Plan (VMP), GMP Risk Analyses (GMP RA) and Design Qualification (DQ).
Torlak, Vaccines Production, Belgrade, Serbia
Installation Qualification (IQ) and Operational Qualification (OQ) of clean compressed air generation and distribution system.
AstraZeneca, Finished pharmaceuticals production, Kaluga region, Russia
Fire and explosion hazard category calculations.
Berlin-Chemie, Finished pharmaceuticals production, Kaluga region, Russia
Fire and explosion hazard category calculations. Development of Logistics section. Conducting GMP Risk Analysis (GMP RA) and Design Qualification (DQ) for clean utilities systems and clean rooms.
Installation and Operational Qualification (IQ/OQ) of clean utilities and HVAC / clean rooms.
Nycomed, Finished pharmaceuticals production, Kyev, Ukraine
Conceptual design development for a new production facility, GMP concept.
Binnopharm, Finished pharmaceuticals production, Moscow region, Russia
Development of production modernization project for aerosols, ampoules and solid dosage forms.
Certification of clean-room structure elements and equipment.
CNT-Zdorovye, Tablets, capsules, suppositories and powder in sachets, Moscow region, Russia
Fire and explosion hazard category calculations. Development of Logistics section.
Development of Validation Master Plan (VMP), conducting GMP Risk Analysis (GMP RA) and Design Qualification (DQ).
Fort, Biotechnological pharmaceuticals production,
Ryazan region, Russia
Project Review, conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ) for vaccines production.
Project Review for vaccines and bacteriophages production.
Fresenius, Dialyzers production, Dubna, Moscow region, Russia
Conducting GMP Risk Analysis (GMP RA) and Design Qualification (DQ).
Gedeon Richter, Finished pharmaceuticals production, Moscow region, Russia
Installation Qualification (IQ) and Operational Qualification (OQ) of pharmaceutical water system.
Niko, Intravenous Solutions, Donetsk, Ukraine
Conduction of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of 2 Rommelag BFS filling systems.
Installation and Operational Qualification (IQ/OQ) of laminar units, including instrumental measurements (particles count, physical parameters, scanning HEPA-filters integrity); development of protocols for qualification (IQ, OQ, PQ) and process validation (PV).
Rafarma, Finished pharmaceuticals production, Kostroma region, Russia
Conducting GMP Risk Analysis (GMP RA) and Design Qualification (DQ) of cold production chain.
Takeda (Nycomed), Finished pharmaceuticals production, Yaroslavl, Russia
Fire and explosion hazard category calculations. Development of Logistics section. Conducting GMP Risk Analyses (GMP RA) and Design Qualification (DQ) for clean utilities systems and clean rooms. Installation and Operational Qualification (IQ/OQ) of clean utilities and HVAC / clean rooms. Performance Qualification (PQ1) of pharmaceutical water systems.
TEVA, Finished pharmaceuticals production, Yaroslavl, Russia
Installation and Operational Qualification (IQ/OQ) of clean utilities and HVAC / clean rooms.
Valenta, Finished pharmaceuticals production, Moscow region, Russia
Conducting GMP Risk Analysis (GMP RA) and Design Qualification (DQ) of pharmaceutical water systems, CIP system and solution preparation system. Conduction of Computer Validation of solution preparation control system.