Laboratory Control System Operations in a GMP Environment. David M. Bliesner

Control System and Its Sub Elements How Things Can Go Wrong: Examples of Some Regulatory Citations Organized by Sub Element Some Final Thoughts on Establishing and Maintaining a Compliance Laboratory Control System

      16  Index

      17  End User License Agreement

      List of Tables

      1 Chapter 2Table 2.1 Components of the laboratory managerial and administrative systems ...

      2 Chapter 3Table 3.1 Model master laboratory SOP index.Table 3.2 Model master laboratory SOP index with details.

      3 Chapter 4Table 4.1 Components of the laboratory equipment program.Table 4.2 Suggestions for laboratory equipment-specific Standard Operating Pr...

      4 Chapter 5Table 5.1 Components of the laboratory facilities sub element.

      5 Chapter 6Table 6.1 Components of the method validation and Method Transfer sub element...

      6 Chapter 7Table 7.1 Components of the laboratory computers system sub element.

      7 Chapter 8Table 8.1 Description of the phases of a laboratory investigation.

      8 Chapter 9Table 9.1 ALCOA+ acronym for data integrity.Table 9.2 Example gap analysis for manufacturing steps.Table 9.3 Example gap analysis for a laboratory instrument data map.Table 9.4a Example risk ranking and filtering tool: Risk definitions.Table 9.4b Example risk ranking and filtering tool: Risk score calculationsTable 9.4b Some Example Lines from the Risk Ranking and Filtering ToolTable 9.5 Example notebook and data review checklist.

      9 Chapter 10Table 10.1 Components of the stability program.Table 10.2 Selection, qualification, calibration, and maintenance of stabilit...

      10 Chapter 11Table 11.1 Components of the general laboratory compliance practices sub elem...

      11 Chapter 12Table 12.1 The laboratory control system sub elements and some example regula...

      List of Illustrations

      1 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.

      Guide

      1  Cover

      2 Table of Contents

      3  Begin Reading

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