GMP is recognized as a vital component of the control of pharmaceuticals. All sites of manufacture for new marketing authorizations, and new sites for existing products, should be cleared with respect to GMP, either by the DRA’s own inspectorate or by means of a WHO-type product certificate from the country of manufacture. Whether local sites are given a general inspection, or whether a separate inspection is conducted for each new marketing authorization, is a matter for local legislation or policy. At least finished-product manufacturing sites should be certified. Guidelines are currently being developed with a view to establishing WHO-type certification of sites at which an API is produced.
DRAs should encourage communication between evaluators and the GMP inspectors. An evaluator reading a dossier must ultimately take on trust much of what the company states, for example that certain equipment is available and is used. An experienced evaluator can sometimes detect discrepancies in the data set that suggest misrepresentation or even outright fraud. In these cases, a GMP inspector is in a position to follow up the evaluator’s queries, and should do so. The inspector and the evaluator should discuss whether the discrepancy is sufficiently critical to warrant site inspection prior to issuing the marketing authorization, or whether it can wait until the next scheduled inspection of the site.
Even when a discrepancy has not been detected, GMP inspectors should make random checks during routine inspections to verify information submitted with applications.