24 years of experience
More than 10 countries
around the world
More than 5
branches and industries
G. M. PROJECT company was established in 1994 and has its roots in pharmaceutical company. During this time, we have developed professional system of engineering activities for demanding clients from pharmaceutical and biotechnological industry, drug products and API producers and laboratories. The company has always been a market leader in these highly specialized activities.
G. M. PROJECT company is principally export company. We export about 80% of the production abroad. We have dozens of satisfied clients in many countries of Central and Eastern Europe. The largest export territories includes Slovakia, Lithuania, Latvia, Poland, Russia, Turkey, Croatia, Kosovo, Iran, Ukraine.
G. M. PROJECT company is an engineering company with huge support of specialist for pharmaceutical, biological and chemical production. Our typical clients are pharmaceutical companies producing finished dosage forms or substances, biotechnological companies, medical devices industry and health-care industry.
Opava - Komárov, Czech Republic
We can prepare customer- tailored workshop either at your company site or at our headquarters in Opava.
We apply a whole range of rules and recommendations, either from government authorities or professional organizations.
... and others
The main methodological base for proper application of regulations and rules is an international professional organization „International Society for Pharmaceutical Engineering - ISPE“, whose instructions and recommendations are widely applied by our company.
We can deliver consultations in all areas of pharmaceutical production and production of medical devices.
Consultation can be performed both in the client location or at G. M. PROJECT headquarters in Opava.
We offer three types of courses:
Public workshops are one-day event held in Holiday Inn hotel in Brno. The aim of this workshops is to deliver and discuss GMP hot topics and news to pharmaceutical industry professionals. The workshops are usually held four times a year.
Public webinar are one to two hours online sessions for pharmaceutical industry professionals. The aim of the webinar is to bring GMP hot news directly to offices in the times convenient for clients. Webinar is also great way to save both time and financial costs.
Client can propose or request workshop according to company expectations and requirements. G.M.PROJECT specialist will help the client to select lectures and topics to develop customer-tailored educational event. Workshop can be performed both in the client location or at G. M. PROJECT headquarters in Opava. We also provide documentation to satisfy Chapter 2 of EU GMP.
Calculation and report of PDE according EMA (European Medicine Agency) – according to new regulation European Medicine Agency – Guideline on setting health based exposures limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), which is valid from 1st of June 2015.
The OEL determination is performed according to ISPE guideline. We calculate PDE (Permitted Daily Exposure), OEL (Occupational Exposure Limit) and elaborate a report which is the basis for risk management and assessment. HERE
The risk assessment is the integral part of the pharmaceutical quality system (ICH Q9). We elaborate risk assessment for customer required process, production, room, system. According to the purpose and assignment we forward results of risk analysis to other teams – designer, validation, realization team or we set corrective and preventive actions with the client (CAPA – Correction Action and Preventive Action). HERE
We also perform audits – regular audits, audits before the inspection, supplier audits. The audit´s output is then the report and the proposal of corrective and preventive actions (CAPA – Correction Action and Preventive Action).
We are providing advisory and consultations in the field of computerized systems. We are following ISPE GAMP5 and ISPE GAMP Good Practice Guides, EU and US regulations of authorities´ rules (CFR 21 Part 11, EU GMP Annex 11).
We provide consultations and advisory services in formation and specification of computerized systems in all stages:
All activities in consultancy, including documents elaboration can be performed in Czech, English or Russian language.