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
Subscribe to:
Post Comments (Atom)
-
Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid... -
K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
-
2.0 Scope: Final visual inspection is performed manually by human operators. Prior to being qualified as an inspector, each in...
No comments:
Post a Comment