Testing a method and proving that it works are not the same thing. What happened? A cleaning method had been tested as part of an allergen-cleaning assessment. However, the results showed very little reduction in allergen contamination. The test had been completed — but the evidence did not demonstrate that the cleaning method was capable of achieving the intended result. Why it matters Validation is not simply about carrying out a test or generating a laboratory result. It i

That might be reassuring… but it isn’t traceability. What happened? Product was returned for repacking, but there was no clear batch identification, production date, use-by date or reliable record linking it back to its original production. The product might have looked familiar, and everyone might have been confident it belonged to the business — but confidence is not the same as traceability. Why it matters Traceability becomes critical when something goes wrong. Without re

That moment during an audit when you suddenly notice something that should not be there… and your brain immediately goes into panic mode. What happened During a warehouse audit, a personal drink was spotted in an area where it should not have been. The immediate reaction was not simply to address the issue, but to wonder whether it could be removed before the auditor noticed. Why it matters The bottle itself is a relatively simple GMP issue. The more important question is wha

A packaging control was in place. The problem? Someone had decided not to use it. What happened During production, a packaging scanner had been bypassed for two days to keep the line running. Without the scanner control, incorrect packaging was able to pass through the process. Why it matters A packaging error isn't always just a quality issue. Where allergen information is involved, the wrong packaging can mean an undeclared allergen, a recall and potentially serious consume