The management of a manufacturing organisation must provide assurance that the (medicinal) products they produce are fit for their intended use, comply with the requirements of the marketing authorisation or clinical trial authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or efficacy. Multiple guidances and regulations apply to your business, and these must be incorporated into your business and quality management system (QMS)

These guidances and regulations are of course incorporated in your business to the best of your knowledge, but there’s always the chance that the interpretation or expectation of the inspector/auditor is different, leading to observations that require remediation.
The best way approach here is to consider these observations as an opportunity to improve the quality of your systems, to increase the assurance that your products always meet the requirements, and further lower the risk for the patient.

What we offer

The remediation of the findings is a service that Adryan offers. If the gap found by the inspector resulted in an undesired outcome, this of course has to be corrected.
The cause of the gap must first be investigated to enable remediation, which will involve improving the applicable processes and procedures, the controls over the outcome, and preventing repetition (CAPA). We can focus exclusively on the observations, or conduct an additional comprehensive scan of the status of your QMS to prepare you for the next audit. (gap assessment)

Robert van Beem

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