Defining Change Management

In this course, the overarching theme has been to answer the question, “What is ‘Change Management’?”  In summary, change management includes:

  • Assignment of a qualified representative for Change Management and Change Control (in the US it’s the Quality Assurance department or “Quality Unit”)
  • Application of knowledge management with understanding of the product (specifications etc.) and process (validated procedures or equipment etc.)
  • Application of risk management with evaluation and analysis of the potential risks of change
  • A formal controlled change control procedure used by the whole company and communication and inclusion of the change process potentially across departments, sites and countries depending on the expanse of the change; and
  • An understanding of the application of change management at various levels of GMP lifecycle according to the stage of development of the product whether it’s for development, continual improvement or through an audit, deviation, or CAPA that the change is required