Q7A says the quality unit should review and approve all appropriate quality related documents. How much scope did the expert group give to this statement? It’s easy to see why production and laboratory documents, but what about maintenance documents? Should the quality unit review and approve a procedure that, for example, tells a mechanic how to put oil into a pump? Another example, should they approve housekeeping procedures?

What you really need to do is balance good judgment and common sense. Typically the quality
unit should review the procedures having to do with scheduling of preventive maintenance and
how the records on these preventive maintenances are kept. Then the quality unit would
typically perform a check of some sort to ensure that preventive maintenance is done on time. But
the quality unit does not necessarily need to review the detailed procedure on how that
preventative maintenance is done. The same thing for housekeeping, where the quality unit
should review the procedure defining how often, who’s going to do it, that sort of thing, but the
details of how it gets done does not necessarily need to be reviewed by the quality unit. The one
exception to that would be if you’ve got micro specifications and the housekeeping really does
impact your API .