Читать книгу Laboratory Control System Operations in a GMP Environment - David M. Bliesner - Страница 4
List of Illustrations
Оглавление1 Chapter 1Figure 1.1 FDA guidance for Industry Quality Systems approach to pharmaceuti...
2 Chapter 8Figure 8.1 The regulatory history of out-of-specification investigations.Figure 8.2 The structure of laboratory investigations.Figure 8.3 A model laboratory investigations work flow diagram.
3 Chapter 9Figure 9.1 The lifecycle of laboratory data.Figure 9.2 Data governance and data integrity hierarchy.Figure 9.4 Example Data Map for the manufacture of a drug product.Figure 9.5 A generic laboratory instrument data map.Figure 9.6 Example laboratory data flow for notebook and data review.Figure 9.7 Quality assurance data and operations audit program work flow.
