Organizing for Retrospective Validation

To this point we have produced a list of products that may be validated retrospectively;
that is, their manufacturing processes are relatively stable, and so
adequate historical data exist on which to base an opinion. The next consideration
is the formal mechanism for validating the individual products. Appropriate
organizational structures for effectively validating processes have been
put forth, but mostly in conjunction with the validation of new product introductions.
Still, these recommendations can serve as models. Because the products
being studied are marketed products, the quality assurance and production departments
can be expected to make major contributions. In fact, as far as retrospective
validation is concerned, it may be more appropriate for one of these
departments to coordinate the project. The research and engineering departments,
of course, will be needed, especially where recent process changes have
been encountered or equipment design is at issue.
Operating as a team, the previously discussed disciplines will determine
which data should be collected for each product and from how many batches;
subsequently, they will evaluate the information and report their findings. Personnel
resources beyond this committee are necessary to accomplish the tasks of data collection and analysis. The time requirements dictate that such work be
assigned to a function with discretionary time, possibly a technical services
group or a quality engineer. Management commitment is especially crucial if
disruptive influences are to be minimized. The loss of a committee member to
another project is such an example.