When is a non-compliance still compliant with regulations? A distributor of medical disposables approached us after discovery of an unauthorised substitution of an active ingredient in a skin cleaning product. We were able to work with the distributor and their manufacturer to arrange testing to quickly confirm the formulation and to establish that although the formulation had been changed the product remained compliant with the applicable pharmacopoeial standard and still met intended purpose and labelling claims. We also assisted to establish the necessary corrective actions and additional quality system controls to prevent recurrence. This information was presented in full to the regulator who agreed that the product still met safety and performance requirements, that the corrective actions taken were appropriate and closed the file with no further action.
When a serious non-compliance is discovered, it’s important to understand not only the technical and quality breakdown but also place that in context of regulatory requirements. This is a time for absolute clarity of information and purpose.
Got a problem with a non-compliance? Need help to regain control? Contact Us for a free, no obligation appraisal