A method for determining what features a Pharmaceuticals Plants should have, and what metrics can be used to measure the quality or performance of the Pharmaceuticals Plants, based on analysis of Clients needs and preferences. The concept engineering process generally includes framing the project, collecting data, analyzing the data, and selecting actions.
Concept Engineering will be a crucial document to decide the project plan and will be a base document for Detailed Engineering.This involves the initial conceptualization of the entire project which helps in forming the foundations on which the rest of the project is built up.
The Concept Engineering will define followings:
- Plant Design Concept with respect to various International GMP guidelines like EU GMP,PIC/S,US FDA and WHO.
- Interface with International Process/ Regulatory Authorities.
- Man and Material Movements.
- Logical Flow for the material and man movement.
- Utilities and Equipments Balancing.
- Time and Cost estimates.
Concept Engineering will have following stages:
This involves gathering functional requirements of the proposed facility which includes production process together with the required level of automation
- Dosage forms
- Batch sizes
- Containment needs
- Type of equipment and machinery
- Inventory norms
- Expansion philosophy
Starts by addressing the following concerns:
1. Preliminary layout based on availability of space and resources
2. Targeted environmental cleanliness category
3. Optimal water quality and water treatment facilities
All the above data are finally used to prepare the following:
An overall budget for project execution The entire facility layout for the preliminary stage as per national and international regulatory norms
- Conceptualization of building construction
- Drawing out user requirement specification (URS)
- Drawing out project schedules through bar charts
- Water generation and distribution system design
- Production environment designing like heating, ventilation and air conditioning
- Pressure differential monitoring