Beth Mole - 4/11/2017, PM Mylan-the pharmaceutical company infamous for raising the price of Epi Pens-is in hot water with the Food and Drug Administration.This time, the dust-up is related to the quality control practices at one of the company's drug facilities making antiretroviral therapies (ARVs) used to treat HIV, Reuters reports.For this reason, the regulator has come up with a revised version of a draft document that was submitted for public comment back in 1998."FDA recognised the need for industry guidance based on our own quality control laboratory inspection findings and the number of inquiries received by the agency on this topic," an FDA spokesperson told In-Pharma What Are The Basic Principles Of Data Integrity And GMP Data Control?While this article is not intended to be a complete summary of Judge Wolin’s decision and all that it discussed, let’s look at some of the data integrity principles the decision contained.
An OOS result is generated when a drug product undergoing release testing or stability testing fails to meet an expected result or specification. 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.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.All test results, both passing and suspect, should be reported and considered in batch release decisions (2). How can we take into account all test results in a rational and scientific manner as required by 21 CFR §211.160 (b)?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.When this happens, the FDA requires a valid reason must be determined to invalidate the OOS result and therefore an investigation into the cause of the OOS result must be conducted.Guidance on this matter is already available for labs, yet difficulties and inconsistent approaches to out-of-specification investigations persist.The agency also claimed that employees didn't bother trying to investigate those failures or prevent them from reoccurring."Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," the FDA wrote.