Prospective
Process Validation
A typical prospective validation study is performed on
at least three consecutive production batches in which the approved operating
parameters are verified to be appropriate for consistently producing product
within all applicable specifications.
Prior to conducting a prospective validation study,
all pertinent process equipment and utilities must have completed and approved
IQ/OQ’s and the analytical test methods to be used must be validated.
CONCURRENT VALIDATION
(Prospective)
(Prospective)
Establishing
documented evidence through the generation of data concurrent with normal
production schedules. Individual batches
may be released for distribution prior to completion of the overall validation
requirements.
RETROSPECTIVE
VALIDATION
Establishing
documented evidence on a process for a product already in distribution based
upon an evaluation of accumulated test data and product history.
The data reviewed in a retrospective validation study
includes:
Quality Control release tests
Stability data
Customer complaints
Process, component and batch formula changes
Compliance with regulatory submissions
Annual product evaluations
Minimum number of lots = 20
