Top reasons for invalidating oos results

09-Aug-2016 09:26 by 7 Comments

Top reasons for invalidating oos results - Completely free milf chats

First and foremost, we need to know that we are able to generate good data — which means our process must be able to reliably produce data we can trust.

As an example, consider this observation from a 483 issued in August 2013: Written procedures … Barr Laboratories In a nutshell, during the years leading up to the 1992 court case, FDA and Barr Laboratories disagreed on what constituted acceptable data handling practices under GMP. Attorney’s Office filed suit against Barr Laboratories.The two cases were combined and heard by Judge Alfred Wolin, and it is Judge Wolin’s landmark decision that became the stake in the ground for current data integrity expectations in the GMP industries.Another example is (), “Rinse all valve parts with water”.But no parameters such as volume of water, time, water pressure or equipment used are given.This encompasses not just our testing and production processes, but also our investigation process for those anomalies.

Per the FDA’s OOS guidance, OOS investigations should occur using a predefined procedure — the procedure defines a standard process but still allows for the appropriate scientific experimentation as needed in the appropriate parts of the process to identify the cause of the anomaly.An introduction to OOT (Out of Trend) results and an overview of the different types and how they are typically handled is also discussed using industry examples in the first session of this course.This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion.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.Much of the Barr Decision related to data management practices in quality control (QC) laboratories and became the basis of the FDA guidance (OOS guidance).