SPECIFIC FEATURES OF DRUG QUALITY ASSURANCE AT THE STAGE OF PRODUCTION
The paper presents the results of the investigation whose goal is to collect and summarize data to determine a sufficient number of basic and auxiliary industrial premises in order to make layouts for a new plot to manufacture ready-made medicaments. The successive steps of creating a new production area are formulated: 1. Development of a design specification (DS). This is a source document for technical object (product) designing. DS establishes the primary use of the developed object, its specifications, quality indices and technoeconomic requirements, instructions to perform required stages for working out the design, program, and other documentation and its makeup, as well as special requirements. DS describes what the customer needs and that the following design documentation shifts emphasis to action - how to achieve this goal. 2. Development of a project. This includes works, plans, measures, and other tasks aimed at designing a new product (equipment, works, and services). Project specification characterization is strictly limited by the contents laid down at the initial stage. 3. Construction and assemblage involve all works on construction, erection of capital equipment and all engineering systems of an enterprise. Prime design costs are required at this stage - there is a need for well-grounded planning, namely, determination of responsibility areas between the principal contractor and subcontractors, and for a schedule for completion of stages. This stage intersects the stages of qualification and validation. It is shown that risks the stage of drug manufacture design must be analyzed.