Audit & Gap Assesment
The management of a manufacturing organisation must be able to provide assurance that the (medicinal) products it produces 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.
Official national and international authorities such as the Dutch Health and Youth Care Inspectorate (IGJ), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) conduct a customary series of inspections to control whether manufacturing organisations are producing according to the valid marketing authorisation dossier. The manufacturing organisation’s clients will also regularly perform quality audits as well.
What we offer
To obtain a detailed oversight of the quality of your organisation in a proactive way, i.e. well before the announced inspection, Adryan can perform a so-called quick scan (gap assessment) of your quality management system, including your quality manual. In this gap assessment, all aspects that could be involved in the planned inspection will be assessed thoroughly, the potential risks will be identified and an effective action plan will be drawn up.
This service that Adryan offers will prevent unnecessary and expensive findings or observations during the inspection. And with respect to any quality-related matters still being addressed with an action plan, your organisation will be able to demonstrate that the non-conformance was identified internally instead of during the inspection. This will give the relevant authorities confidence that your organisation will stay in control by properly taking care of the quality system in place.
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Audit & gap assesment