In the context of Good Manufacturing Practice (GMP; German: Gute Herstellungspraxis), prospective validation is a validation process that, in contrast to retrospective validation, is carried out before a product is manufactured commercially. This is the usual procedure, as an exclusively retrospective validation is generally not accepted as GMP-compliant.

Prospective validation (translation into German: prospektive Validierung) should include the following elements, among other things:

• Brief description of the process
• List of the critical process steps to be examined
• List of the systems/equipment used (including measuring, monitoring and recording devices) with information regarding their calibration
• Specifications for the end products upon release (German translation: Freigabe)
• List of the analysis methods, if necessary
• Proposed in-process controls and acceptance criteria
• Additional tests to be carried out if necessary, together with acceptance criteria and validation of the analysis methods
• Sampling plan
• Methods for documenting and evaluating the results
• Tasks and responsibilities
• Estimated schedule for the tasks to be carried out

Prospective validation ensures that new or modified manufacturing processes meet all GMP requirements before the product is manufactured on a large scale.

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