Management of Change
MOC
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The organizational discipline for identifying, assessing, and controlling the quality and compliance impact of personnel, organizational structure, facility, and business changes before they take effect — broader in scope than document-level change control, which governs changes to a specific procedure, specification, or system.
Where change control typically governs a single controlled document, specification, or system change through a defined workflow, management of change addresses organizational-level shifts — a reorganization of the quality unit, a change of contract manufacturer, a new IT system rollout, or a facility relocation — whose downstream GMP impact may not be obvious from any single procedure.
ICH Q10 frames the change management system as a pharmaceutical quality system element that should evaluate the quality impact of both proposed and unplanned changes, using quality risk management to determine the level of scientific and technical review required before implementation.
A weak boundary between management of change and routine change control is a recurring inspection gap: organizational changes are sometimes implemented without any documented quality impact assessment simply because no single procedure “owned” the change.
- —Broader than document-level change control — covers organizational, personnel, and facility change
- —Uses quality risk management to size the review needed before implementation
- —A pharmaceutical quality system element under ICH Q10
- —Gaps often occur when a change has no single procedural owner
ICH Q10 (Change Management System, a Pharmaceutical Quality System element)
Frequently asked questions
What does Management of Change stand for?
Management of Change stands for MOC.
What is Management of Change?
The organizational discipline for identifying, assessing, and controlling the quality and compliance impact of personnel, organizational structure, facility, and business changes before they take effect — broader in scope than document-level change control, which governs changes to a specific procedure, specification, or system.
Which regulations cover Management of Change?
ICH Q10 (Change Management System, a Pharmaceutical Quality System element)