Types of Validation

Prospective -
At least three successive production-size (US view)
batches, all batches made, tested, and report approved before
distribution, facilities and equipment qualified
Concurrent -
Generation of validation data concurrent or
simultaneously with normal production schedules. Used in exceptional
cases (low volume products); interim reports required.
Retrospective -
based upon accumulated manufacturing, testing, and
control batch data (EU Annex 15); least preferred approach (used
typically for mature products), no changes during period, assess critical
test results of at least 20 batches

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