Conceptual design

Conceptual design is the next step after feasibility study. It is developed together with site master plan. Conceptual design is a preliminary study to define the initial requirements of spaces, facilities, process equipment and required ancillary systems, to comply with the main GMP principles as well as local and international standards.

The importance of conceptual design

Conceptual design is actually the foundation of a project on which total investment will be done. It is the origin of all project successes and failures. Enough attention should be paid to this stage of designing and a team of GMP and engineering experts should be involved. Team members are specialists who not only have enough general knowledge and experience regarding pharmaceutical projects, but also should completely know GMP regulations and specific processes of the project.

The main goals of conceptual design are:

• Define the size and capacity of the facility
• Develop production scheduling based on a sales forecast
• Identify and size the major equipment systems
• Get an estimated investment budget

Conceptual Design is a key step to develop a fully GMP compliant design that considers processes, technologies and equipment, making them fit in the given space.

Without a proper Conceptual Design, a lot of changes may be occurred during later steps of the project, which have not been studied deeply in the beginning as possible options.