who is dan abrams dating 2016 - Top reasons for invalidating oos results

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.

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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.

There are two well-established ways of taking an OOS result into consideration in arriving at a reportable result.

Firstly, we will look at isolating the OOS result using a standard confidence interval approach.

It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards. FDA felt that Barr Labs’ control practices — including release of product not meeting specifications, inadequate investigations of failed product, failure to control product manufacturing steps, and averaging of testing results — were not sufficient to ensure that products meeting its quality standards were distributed to the public. The company’s argument, though, was that the practices FDA claimed it needed to follow were not specifically required by the GMPs.

To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it. In response, Barr sued FDA for practicing “ad hoc” drug regulation.

The article, however, did not address the vexed question of how to calculate the reportable result.

Retesting is only performed if a root cause for the OOS cannot be established.

In such cases, the FDA requirement is specific: If no laboratory or calculation errors are identified in the first test, there is no scientific basis for invalidating initial OOS results in favor of passing retest results.

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