Pharmaceutical facility design is the search, approval, and implementation of optimal engineering, technical and technological design solutions meeting GMP requirements.
The design of pharmaceutical facilities involves tackling several essential tasks:
-
Development of a production process that takes into account options for raw materials and starting materials, stages of intermediate and finished product production taking into account risk assessment, and all requirements and limitations;
-
Ensuring the consistency of the process, alignment of all stages and operations into one consecutive chain, avoiding mix-ups or omissions;
-
Meeting requirements for cleanrooms and protection zones of critical process operations as well as meeting cleanroom classification and pressure differential requirements;
-
Implementation of architectural and design solutions with due regard to GMP requirements;
-
Identification of measures to prevent cross-contamination;
-
Installation of utilities and cleanrooms according to process needs;
-
Efficient design of workplaces.
Pharmaceutical production design. Stages
First of all, the design of a pharmaceutical facility means the development of a conceptual design, which must pass an expert evaluation (design qualification).
Conceptual design is the first phase of the design process, the fundamental basis for creating any project.
Design qualification (DQ) is a documented verification that the proposed design of the pharmaceutical facilities meets the User Requirements Specification (URS) and GMP.
Based on the conceptual design that has passed qualification, pharmaceutical facility design is carried out; design and working documentation are developed.
The pharmaceutical projects that are most in-demand are the production of suppositories, tablets, aerosols, and sprays.