Effective Change Management – An Extractables and Leachables (E&L) Perspective

Effective Change Management –  An Extractables and Leachables (E&L) Perspective

Change control is a term that describes the process of directing how changes are introduced into a validated process to ensure the consistency of the final product. Any change to a validated process (including component parts or conditions) or to a regulatory approved product requires an assessment that demonstrates that the quality and efficacy of the final product will not be negatively effected by that change. Change control, or management of change, is the documented process by which this assessment is conducted. 

Changes can be planned or unplanned and will have varying degrees of impact that could affect the quality or efficacy of a drug product. Changes are categorised as either minor, major, or critical and require different approaches to implementation dependant on the type of change.

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