Piot batch, validation batch & commercial batch

What is the connection between pilot batch, commercial batch & validation batch?

I think the connection between them can be better understood if we consider the purpose of each one, and when in the lifecycle of the product are they being manufactured. In short:

Pilot batch allows you to define the manufacturing process (parameters, controls, etc.), validation batches allows you to demonstrate that process is effective, and commercial batches are the ones that you can release for sale once process is validated.

  • Pilot batch: As with any other batches manufactured during process development and technology transfer, the purpose of these is to gain knowladge of the process and define a control strategy to it, identifying critical process parameters, matieral characteristics, product critical quality attributes, etc. Pilot batches are commonly referred to those done in a pilot plant, and are usually where the compounding of the product is tested in small scale. Transfer batches, or scaling batches are usually when tring to reproduce a batch in a commercial scale.

  • Validation batch: with the knowledge gained from pilot, experimental, engenieering, develpment batches, etc. These are manufactured for validation purposes, to demonstrate that the control strategy is effective in ensuring product quality. Consider that the batches manufactured for PPQ (process performance qualification) most be commercial batches.

  • Commercial batches, these are all batches that are manufactured for commercial purposes, process must be validated to manuacture these; exceptions to this are:

    • PPQ batches for prospective validation: cannot be released until validation is approved
    • PPQ batches for concurrent validation: can be released lot by lot before validation is approved, but require compliance with more robust criteria and can only be done when low half lives, low demand or health emergency situations are present.