What is Change Control and Its Types? : Pharmaceutical Guidelines

What is Change Control and Its Types?


Change control is a system that controls change by:
  • Identifying ownership of the change 
  • Allowing for review and approval of the change. 
  • Prevent changes those could affect product quality or regulatory requirements. 
  • Providing an assessment of change and monitors the impact of change. 
Level 1 (Minor): Are those that are unlikely to have any detectable impact on the quality attributes of the product.
Level 2 (Major): Are those that are likely to have a significant impact on the quality attributes of the product.
The type of reasons for change control:
  • Regulatory requirement 
  • GMP implementation/ enhancement 
  • Quality improvement 
  • Capacity enhancement 
  • Introduction of new product in an existing facility 
  • Cost reduction 
  • Automation 
  • Aging of facility 
  • To manage the unavoidable situation 
  • Market requirement



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