Top reasons for invalidating oos results
In a letter to Mylan, the FDA outlined several violations at the facility, based in Maharashtra, India, and warned Mylan to shape up.Specifically, the FDA said that investigators found that facility employees inexplicably invalidated quality control data that showed that drug batches didn't meet standards.
Retesting is only performed if a root cause for the OOS cannot be established.
The intention of this long-anticipated document is to establish a risk-based frequency of regulatory inspection for pharmaceutical companies through review of quality metrics data on lot rejection rates, frequency of invalidated out-of-specification (OOS) results, product complaints, and on-time rates for annual product and quality review reporting.
Quality metrics reporting would justify reduced general, pre-approval, and post-approval manufacturing change inspections and improve overall quality in the pharmaceutical industry.
Requests would extend to contract manufacturers, sterilizers, and packagers of the drugs covered by the guidance.
Excipient and packaging component manufacturers are out of the scope of this guidance document.