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.
ISPE Good Engineering Practice is G. M. PROJECT methodology for designing according to the ISPE BASELINE® and Good Practice Guides of the „International Society for Pharmaceutical Engineering - ISPE“, which are widely applied in G. M. PROJECT company. When designing, we start from initial Risk Analysis and offer practical solutions in standard development of design documentation in different stages:
As per client requirements, we are ready to elaborate 3D drawings. The dwg format is usually used for drawing. The design documentation can be provided in Czech, English, Slovak, Russian or many other languages.
The integral part of designing solutions is also the access to the Project Management and validations. We always follow these approaches:
We elaborate the design documentation for new or renovated Facilities or units for manufacturing Final Dosage Forms or Active Pharmaceutical Ingredients including utilities and necessery infrastrukture.
In Studies and Conceptions we advice to our clients and help them to decide key parameters of future manufacturing as production capacity, technology and utilities solutions, energy requirements, waste management and project managemant and financing. We develop more options or variants so the client can choose the solution which suits the best for the purpose.
We work out the documentation according to the local law requirements in a country of facility location.
We provide Design Documentation in a full-range support including Environmental Impact Assessment (EIA) and legal requirements in a country of facility location. We can also deal with local government administrations and authorities.
We can assist with User Requirement Specification concept to allow our customer to specify their requirements with respect to GMP requirements, technical standards and functionality. The URS is key document for next Design Development steps.
In collaboration with client, we can work out concept of tender (request) documentation. Such a document is a set of requirements, entries and technical conditions of the investor to allow suppliers to offer equipment, systems or services with respect to requirement.
Basic Design is an essential document for planning purchases of all designed parts, equipment, systems and components including validation and qualification of the whole project including construction. Basic Design is also a foundation for Validation Master Plan and building construction project. It is typical Enhanced Document for Direct Impact System with standard solution of Indirect Impact System. Function Design or Specification is main goal of this document.
Detail Design is the Basic Design further work out into very details to allow proper realization and proper functioning of all equipment and systems. Detail Design is developed on the Basic Design document as Project Specification of all details. Basic Design and Validation Master Plan are main documents for Detail Design work coordination. We collaborate closely with suppliers of construction work, equipment, systems and services in this stage. Some parts of Detail Design are designed by specialists under G. M. PROJECT coordination as part of Project Management.
So called As-built Documentation is prepared after installation of all machines, equipment and systems. This documentation records all changes in installation and specification occurred after previous documentation stages. This documentation is internal part of supplier documentation and is usually required for Installation Qualification.