FDA: Guidance for Industry on Drug Inspection
On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. The guidance intends to clarify how the law under Section 707 of FDASIA (Food and Drug Administration Safety and Innovation Act) will be interpreted and put into practice by the FDA.
The guidance defines the kind of actions, inactions and circumstances that the FDA considers to lead to problems and gives examples to illustrate the most common situations that the authority has encountered in preparing for and conducting inspections as well as situations that FDA anticipates may occur. If a facility fails to respond to FDA attempts to contact it, it is considered to be an unreasonable delay. Or if after scheduling an inspection a facility requests a later start date without giving a reasonable explanation. But there are examples explaining what levels of “reasonableness” the FDA might tolerate, as well. For example, the FDA would be fine with delayed access to an area, if it were done to allow an inspector to comply with the facility's documented gowning procedures, in order to prevent contamination.
Some critical voices already say that the guidance creates issues rather than clarifies issues and that the term “reasonable” offers additional margin for manoeuvre.
Please click here for more information and for direct access to the final guidance.
In this context the FDA has introduced a Data Dashboard on its website. It offers direct access to information and analysis about all inspections performed by the FDA. Summary reports and trends, diagrams and warning letters are provided. According to FDA, the FDA Data Dashboard is a tool to share inspectional, compliance and enforcement related data in various, easily understood graphical formats.
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