Every sector below works under GMP, and every one of them fails in a different place. What follows is where the exposure actually concentrates in each, and what we are most often asked to do about it.
If your operation sits across two of these, that overlap is usually where the gap is: nobody owns the seam between two frameworks.
Finished dose sites working under EU GMP Part I with a national inspectorate and, often, a second market's expectations layered on top.
QMS effectiveness. Recurrence visible in the site's own deviation record.
Annex 1 raised the bar on contamination control strategy, and it did not raise most sites' headcount to match.
A contamination control strategy assembled from existing SOP references rather than written as a strategy.
Scaling from clinical supply to commercial, where the quality system was built for flexibility and now has to be built for repeatability.
Validation and specification setting arriving after the process is already running.
ISO 13485 and MDR technical documentation under notified body scrutiny and capacity constraints that do not forgive late submissions.
Post-market surveillance and clinical evaluation not feeding back into the file.
Audited repeatedly by clients as well as regulators, with every audit costing days that are not billable.
A different story told to each client because nobody maintains one canonical version.
ICH Q7 obligations plus customer qualification demands, where a single supplier finding propagates downstream to every customer at once.
Change control that does not notify the customers whose filings depend on it.
Temperature control, qualification of transport routes and the responsible person role, with a licence that is straightforward to jeopardise.
Temperature excursion handling treated as logistics rather than as a deviation.
Sites operating to GMP principles without a GMP licence, usually because a customer, a retailer or an export market demands it.
Documentation that satisfies a customer audit but would not survive a regulatory one.
If you manufacture under a quality system that someone external inspects, the method transfers. Tell us the framework and we will tell you honestly whether we are the right people.
Fifteen minutes is enough to establish whether the method fits your sector, and we will say plainly if it does not.