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.
The aim of validation, qualification and verification is to proof that facility, system and equipment fit its intended purpose. Validation, qualification and verification documentation is a written documentation to proof that the facility, system and equipment comply with pre-defined requirements represented as Critical Process Parameters and Critical Process Attributes.
Qualifications and validations are performed according to Eudralex guidelines, The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Product for Human and Veterinary Use, Part 1, Annex 15 and if appropriate, other relevant legislative requirements are applied. HERE
We perform following validation processes:
We perform qualifications, validations and verifications of all systems and equipment in pharmaceutical and chemical industry, in medical devices industry, in production and filling of medical gases, in health care facilities, hospitals, blood centres and pharmacies. We collaborate with electrotechnical and car production industry, including measurement and testing in Ex hazardous locations.
We always work together with the client in closely-knit validation team. Before qualification and validation works, we elaborate validation protocols. Testing is initiated upon validation protocol approval and completed by validation report.
We perform qualifications and validations of following systems and equipment:
We perform validations also for computerized systems in various stages:
For these activities, we follow ISPE GAMP5 and ISPE GAMP Good Practice Guides, European and US legislative regulation of regulatory authorities (CFR 21 Part 11, EU GMP Annex 11). We perform qualifications and validations of computerized systems in following stages: installation testing, functions testing, whole system testing (IQ, OQ, PQ).
The validation documentation can be elaborated in the Czech, English or Russian language.