Once the decision to go ahead is taken (based on the feasibility study) the project goes ahead and once a Site Master Planning has been agreed, the Conceptual design is a preliminary study and definition of the initial requirements of spaces, installations, process equipment and required ancillary systems, to comply with the main GMP requirements as well as local and international standards.

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 key to the development of a fully international GMP compliant design that considers processes, technologies and equipment, making them fit in the given space.

Without a proper Conceptual Design, any later step of the facility may assume many changes, which have not been studied deeply in the beginning as possible options.

 

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Site Master Planning

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