GMP (Good Manufacturing Practice) – a system of guidelines and quality standards in the production of pharmaceuticals, active ingredients, medical devices, diagnostic products supplies, foodstuffs and food additives.
The Lab & Pharma companies adhere to the principles of creating effective production according to GMP standard, keeping up with modern technologies.
Our companies have been positioning themselves as leaders in the field of engineering and pharmaceutical services. We offer our Customers design services for industrial facilities and health care institutions in such areas as:
- The pharmaceutical and biotechnological industry (factories, production sites, laboratories, warehouses, vivaria, etc.);
- Veterinary industry (factories, production sites, laboratories, warehouses, etc.);
- Health care institutions (centers of positron emission tomography and computed tomography, operating units, intensive care, sterilization, laboratories and other institutions).
In creating our designs we take into account all the principles and requirements of GMP standards, consistently maintaining a high level of quality. The company develops solutions that best meet the functional requirements of an object, especially its location and destination.
Design is carried out in stages, in accordance with national regulations and in agreement with the Customer. In general approach the design is performed in the following stages:
- Development of the Conceptual Design;
- Development of the Basic Design stage on the basis of the concept adopted for state review;
- Development of the Detailed Design stage for further construction;
- Documentation of actual implementation.
Conceptual Design stage of the project is the first phase, the basis for creating any object. It allows to calculate the means and opportunity for investor`s plans, defines the requirements for functional solutions of an object. A well-designed concept ensures a solid foundation for further design actions at the object.
On the basis of the Conceptual Design the Basic Design stage is developed to determine the urban planning, architectural, environmental, technical and technological, engineering solutions object, the estimated cost of construction. This phase of the project is necessary for passing the expertise and obtaining permits.
The Detailed Design stage is developed with details necessary for construction and installation works, and also manufacturing of non-standard products.
The documentation package complies with the standards and regulations in force in the country of the Customer.
After the development of the project documentation, our specialists carry out supervision over the implementation of the project.
For existing companies we offer:
- Analysis of possible defects, solution and their correction;
- Consultations in the field of GMP, technological equipment and systems, cleanrooms, monitoring of critical parameters.