What is the primary purpose of a robust change control process in GMP?

• A. To prevent any changes from ever happening.
• B. To outsource all quality decisions.
• C. To manage changes with risk assessment and documentation.
• D. To increase production speed without checks.

Answer: (C)

A robust change control process ensures that any proposed modification is carefully evaluated for its potential impact on product safety, quality, and regulatory compliance, and that it is properly documented and approved before implementation. By conducting a risk assessment, the team identifies which quality attributes or process parameters could be affected and determines whether additional testing, validation, or requalification is needed. All changes are recorded with clear rationale, responsibilities, and evidence, providing traceability and accountability for audits and regulatory reviews. This approach prevents unintended consequences from changes, supports consistent product quality, and enables safe, approved improvements rather than ad hoc alterations. Options that suggest blocking all changes, outsourcing quality decisions, or speeding production without checks miss the purpose of controlled, informed modification and patient safety.