Lean Biomanufacturing

List of tables

1.1. Targets for Lean implementation 7

1.2. SIPOC key points 17

1.3. SIPOC chart 17

1.4. Quality by Design: a comprehensive systematic approach to pharmaceutical development and manufacturing 21

1.5. Areas affected by Lean principles 23

1.6. Similarities comparison of Lean and Theory of Constraints in terms of operating principles 25

1.7. Lean manufacturing and Theory of Constraints differences 26

2.1. Key for value stream mapping: basic symbols 42

2.2. Box score 43

2.3. ‘5 Whys’ analysis 59

3.1. Examples of Key Performance Indicators 101

3.2. FMEA worksheet 103

3.3. Example of an FMEA worksheet 103

3.4. Elements related to rebuilding the Quality Management System 108

3.5. Quality System Remediation Transformation 109

3.6.  ...