Technical/Engineering Consultancy
- Plant design and revision
- Creating architectural and cleaning class flow layouts in line with process flow and GMP concept
- Designing ail flow directions, pressure values in line with WHO, ISPE and FDA Regulations
- Designing and projecting of raw material, semi finished goods, personnel, packaging, finished goods and waste flows in line with GMP and related regulations
- Sterile process, oral process designs (Manufacturing, transfer, filling, control and packing)
- Defining infrastructural requirements by making utility consumption analysis
- Machnine/equipment qualification (IQ+OQ+PQ), validation works and consultancy services concerning with these
- Providing required GMP and technical trainings
- Preparing for inspection, GAP analysis, making and observing action plans
- Creating capacity analysis, capacity optimization, machine, equipment choosing tables, feasibility analysis
- Making cost reduction programs
- Laboratory designs
- Project management and consultancy
- Creating related UGS’s and risk analysis
- Reviewing computerized system validation, inspection, interoffice expertise training, making validation activity documents
- Reducing and optimization of process and manufacturing costs in line with GMP rules