Process Validation

Hello everyone,
Good day to you.
please help me in following issue.

What are the difference among Prospective validation, Concurrent Validation, Retrospective Validation. please help me with reference or example for easy understanding.

Thank you in advance.

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The main difference is when the validation starts and ends in relation to process implementation and product release/distribution.

You can read more about it in FDA’s guidance for industry: Process Validation and EU GMP’s Annex 15 Qualification and Validation

Prospective validation:

  • Concept → PPQ is completed and approved before releasing PPQ lots.
  • When → Should always be the approach to follow.
  • Risk → Lowest risk, since there is documented evidence of process performance and understanding of process variation before releasing the lots.

Concurrent validation:

  • Concept → PPQ lots are released lot by lot before actually completing and approving PPQ.
  • When → Rarely used, only when prospective cannot be followed due to limited demand, short half lives or national health emergency.
  • Risk → High risk. Process performance consistency has not yet been demostrated lot by lot (Low understanding of process variation) before releasing PPQ lots. PPQ lots to be released must comply with GMP, regulatory and robust PPQ protocol requirements.

Retrospective validation:

  • Concept → No PPQ lots. Validation is done after a process is already implemented and product is being released and distributed. Validation is done by analysis of historical data and past/current process perofmrnace.
  • When → Is not acceptable anymore by most health regulation entities.
  • Risk → Highest risk, product release criteria does not include any Validation or PPQ requirements to have a better level of assurance that process perofms as intended. No understanding of process variation before releasing lots.

I hope this is helpful.

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Its really helpful. thank you very much for your elaborate description which is better understandable for me.

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