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.
Agreement now operational between 12 EU Member States and FDA . The US Food and Drug Administration (FDA) confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA can rely on to replace their own inspections (including already confirmed countries - Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom).
PIC/S has announced that revised Annex 1 on the Manufacture of Sterile Medicinal Products has reached Step 2 of the revisions. The draft canaccessed here
On 9th October 2017, European Medicinal Agency (EMA) issued new guideline - Annex to theEuropeanCommissionguideline on ‘Excipients in thelabelling and packageleafletofmedicinalproductsforhuman use’ (SANTE-2017-11668)
See the link to EMA website:link
Dead line for risk assessment for element alimpuritiesisapproaching fast. We are ready to workout your ICH Q3D Elemental Impurities risk assessment for your drug product or drug substance!
European Medicines Agency (EMA) issued a new document (EMA/CHMP/CVMP/SWP/463311/2016) „Questions and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012)”, which further specifies how to determine and interpret HBEL. The document also identifies highly hazardous compounds, and „safe“compounds for which a traditional cleaning limit approach (e.g. 1/1000 of therapeutic daily dose) can be applied.
The European Union (EU) and the United States (US) have signed a mutual recognition agreement (MRA) for inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic. This MRA means that EU and US regulatory authorities will be able to rely on each other’s information as regards facilities in the EU or US that manufacture medicines and active pharmaceutical ingredients for the European and American markets.
In their blog the FDA says it has committed to enter into a similar agreement with UK post Brexit if necessary.
We offer risk assessment of „Toxicological aspects of GMP“
Publishing of EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities and ICH Q3D Guideline for Elemental Impurities brings new approach of setting quality attributes to drug manufacturing. This new approach combines toxicological assessment, aplication of toxicology science and risk assessment according to ICH Q9. The methodology follows approach initiated several years ago by International Society for Pharmaceutical Engineering (ISPE) called Science and Risk Based Approach.
For introduction and implementation of this approach into practise, we offer consultation and/or workshop conducted by qualified toxicologist who answers all abreviations like NOEL/NOAEL, LOEL/LOAEL, LD50, PDE, ADE, OEL, where they come from, what is their meaning and how to apply them.
G.M.PROJECT s.r.o. participated in the 19th „Export Award DHL UniCredit“ under CzechTrade agency and won 4th place.
Export Award DHL is traditional award in Czech export industry and anticipates small and medium size businesses with significant export dynamics growth. The competitions was established by logistics company DHL Express CZ in 1997 to motivate exporters to conquer international markets for their products. The award is organized under the auspices of CzechTrade – government agency – since it has been established. General partner of the award is UniCredit Bank and also collaborates with Association of small business and freelancers, Czech Republic. Company Coface Czech is a professional sponsor of the award. Highest ever number of 160 participants submit their applications this year, while 146 fulfilled conditions of the competition.