Proper handling of Out of Specification (OOS) result is the hallmark of a robust investigation

[Adam Fleming]

The whole exercise of drug making is incomplete and unthinkable without laboratory testing. There is no better indicator of success on the part of the drug manufacturer than this activity. This is absolutely essential as a means for confirming that all the ingredients that make a laboratory product, such as the raw materials used in it, the in-process materials as well as the finished materials that go into it, and containers as well, all kowtow to the set, required specifications. This is why current Good Manufacturing Practices (cGMP) regulations are very stringent and uncompromising when it comes to laboratory testing.

Now, what does a laboratory do when its laboratory testing comes up with an Out of Specification (OOS) result? It is necessary to understand that an OOS is not something that is taken lightly. It is taken very seriously and handled very stringently by the FDA. Being the regulatory watchdog under whose watch the whole range of laboratory activity falls; the FDA is carries out laboratory operations extremely closely. It expects complete and total compliance with its requirements on the way laboratories are expected to investigate Out of Specification and Out-of-Tolerance observation investigations.

Under FDA’s Sec 211.165, cGMP regulations reject any finished Out of Specification products that do not comply with the set specifications, as well as its mandated safety and other quality standards. These cGMP regulations also mandate complete investigation of test results that demonstrate any deviation of the contents of a batch from the specifications. These cGMP rules apply irrespective of whether batches have been released into the market or not.

How do labs deal with OOS results?

The application of current Good Manufacturing Practices into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals is required under FDA’ Section 501(a) 2 (b) of cGMP guidelines on OOS. OOS testing is mandatory for any batch that is being released.

These are what cGMP regulations require laboratories to do when they observe and confirm an Out of Specification testing compulsory for the release of a test batch: Confirmation of an Out of Specification result causes the batch to get rejected. If a laboratory test result throws up an element of ambiguity, then cGMP regulations require the company’s Quality Assurance (QA) to both mention the reasons for the release and to offer justifications for it.

The FDA guidance on Out of Specification covers human drugs, biology and biotechnological products, combination products, veterinary drugs; type medicated articles, transplantation of human tissues, medicated feed, finished products & active pharmaceutical ingredients and dietary supplements.

A learning session on the vital aspects of OOS

These aspects of OOS results will be the topic of a highly interesting and valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this webinar, Danielle DeLucy MS, who is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance, will be the speaker.

To enroll for this webinar and to gain complete understanding of how to handle OOS test results, please visit http://www.compliance4all.com/control/w_product/~product_id=501333L...

The aim of this webinar is to guide attendees through the entire process starting from detecting an OOS result to launch and completion of informal and formal laboratory and batch investigations. This will help companies understand where they are going wrong, as it has been consistently observed that most companies do have procedures in place, but these are either inadequate or are not followed.

                                                                   

At this webinar, Danielle will professionals in the area of lab testing, such as Quality Assurance/Quality Control Directors, Managers, and Specialists, Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists, as well as Quality Control Laboratory Staff the responsibilities of analysts and supervisors. She will also enlighten them about how to listen to what the FDA looks for in terms of human errors, which will give them a good idea of what to do and what to avoid. She will also explain the situations in which a full investigation should be triggered, the frequency for re-testing and re-sampling, and the proper ways of implementing corrective and preventive action (CAPA) plans.

http://www.fda.gov/downloads/drugs/guidances/ucm070287.pdf

http://sphinxsai.com/2013/JulySept13/phPDF/PT=11(943-948)JS13.pdf