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  • hv42 replied to the topic How Quality Departments React to Audits in the forum Quality Control and Quality Assurance 7 years, 6 months ago

    From a quality perspective, I will say that I have follow all the rules to make this product and I have all the documents in details from the start to end of the project with good GMPs. The quality person will only be afraid of hopefully he did not miss anything and they don’t get bad audit report or a 483 because it is embarrassing for the company in the market, It shows that company has a deficiency which can affect in future when you go to FDA to get your product approved and now they will look at every single thing in detail and give you hard time. So quality people is worried about the companies image and reputation in the market and in front of FDA from this audits.