29 questions to ask about your change management/change control system

While these questions are very pharma/biotech specific in places, they should serve as thought process for your own system checkup.

  1. Is there a written SOP covering the change control program that has been approved by the Quality Unit?
  2. Do procedures in place describe the actions to be taken if a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducibility/robustness of the process?
  3. Does the SOP ensure that all GMP changes are reviewed and approved by the Quality Unit?
  4. If changes are classified as “major” or “minor,” do procedures clearly define the differences?
  5. Does your change management system include criteria for determining if changes are justified?
  6. Are proposed changes evaluated by expert teams (e.g. HSE, Regulatory, Quality…)?
  7. Is there a process for cancelling a change request prior to implementation? And Is a rationale for cancellation included?”
  8. Does your Change control management site procedure describe clearly the process to close a change request (After all regulatory approvals…)?
  9. Are any delays explained and documented?
  10. Is there a written requirement that change controls implemented during normal or routine maintenance activities be documented in the formal change control program?
  11. Is your change management system linked to other quality systems such as CAPA, validation, training?
  12. Does your change management system include criteria for determining if changes will require qualification/requalification, validation/revalidation and stability studies?
  13. Are “like for like” changes (changes where there is a direct replacement of a component with another that is exactly the same) clearly defined in all aspects (including material of construction, dimensions, functionality,,,) ? Are they adequately documented and commissioned to provide traceability and history?”
  14. Is there an allowance for emergency and temporary changes under described conditions in the procedures?
  15. Are the proposed changes evaluated relative to the marketing authorization and/or current product and process understanding?
  16. Does your change management system include criteria to evaluate whether changes affect a regulatory filling?
  17. When appropriate are regulatory experts involved? Does the regulatory affairs function evaluate and approve all changes that impact regulatory files?
  18. Are changes submitted/implemented in accordance with the regulatory requirements?
  19. Is there a defined system for the formalization, roles and responsibilities for change control follow-up?
  20. Is the effective date of the change (completion date) recorded and when appropriate the first batch manufactured recorded?
  21. Is there a periodic check of implementation of Change controls?
  22. Following the implementation, is there an evaluation of the change undertaken to confirm the change objectives were achieved and that there was no adverse impact on product quality?
  23. Is all documentation that provides evidence of change, and documentation of requirements, controlled and retained according to procedure?
  24. When necessary, are personnel trained before the implementation of the change?
  25. Are change controls defined with adequate target dates?
  26. If the change control goes beyond the target date, is there a new date attributed, evaluated and documented by Quality Assurance?
  27. Are there routine evaluations of the Change controls and trends (number, Change controls closure, trends as defined)?
  28. Are changes closed on due date ?
  29. Are the Change controls and follow-up formalized in a report and/or periodic meetings?

These sort of questions form a nice way to periodically checking up on your system performance and ensuring you are moving in the right direction.

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