Pre-designing is the first step in creation of a new production facility. Due to high-quality study of pre-designing documentation, the task of obtaining initial permissions (IP) from relevant authorities is facilitated, designing time is shortened, it becomes possible to choose the best possible solutions and to select equipment during designing.
The pre-designing is concluded by development of a final version of the concept design and approval of design performance specification.
The designing result is a set of detailed drawings for all sections, accompanied with a general explanatory note and summary estimate.
Based on the design documentation, a customer has complete information on the required scope of investments, duration of works needed to create the production facility, production capacity of the future enterprise, staff listing and necessary scope of power supply.
At this stage, necessary equipment is approved by a customer, ordered for production and accepted. The equipment pool is supplied to the site in accordance with the list approved and stipulated in the design within the specified time.
The CIW are related to creation of new or overhaul, restoration, upgrade of existing sites, on the basis of which a production complex will be created. A decision to perform construction and installation works is made after a comprehensive analysis of the technical condition of a facility, that is, engineering surveys as well as technical and economic feasibility.
This stage includes activities which a company must perform to install supplied equipment, connect the equipment to process media and existing power supply, and to test individual elements. After successful safe and fault-free trial runs of all individual units of the system, they are integrated into a single operation loop. The final stage of the commissioning is operational commissioning of a production facility.
When creating pharmaceutical production facilities, a new facility validation starts with qualification of its design documentation (DQ - design qualification). The next step of the validation process is qualification of installation and qualification of supplied and installed equipment operation (IQ/OQ - installation qualification / operation qualification).
The next stage of the validation is qualification of stable performance of all elements in the process line (PQ - performance qualification). The final stage of integrated solutions is training of customer’s personnel and necessary validation of processes, drawing up of appropriate documentation (PV - process validation).