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Particulate matter in parenteral drugs has been recognized as a potential health hazard.

Incorrect test results at extremely high blood glucose levels.

If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.

Patients are at increased risk of infection in the event a sterile product is compromised.

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.

In the world these days, we have more access to data than ever before.  Whether through social media, smartphone integration, or enterprise systems - we blur the line between what's business and what's personal.  With the enormous amount of data filtering through our brains, we instinctively look for ways to make sense of things.  We try to figure out "what's trending" - whether with celebrity gossip, sports teams, or in the case of Quality Management Systems, adverse events. 

Next week, we're going to be holding a webinar with LNS research to discuss exactly what's trending in Quality Management, specifically in Life Science.  Our good friend and rockstar analyst Matthew Littlefield will be showing some data from over 100 companies on what is most important to Quality, Risk and Compliance in the Life Science industry.  I thought I would throw my hat in the ring and outline a few trends we see in the market from a process automation perspective.

1.  Linking Adverse Events to Corrective Action:  We see companies handling adverse events within the Quality Management System, but the key concept they are looking for is visibility and traceability.  Any way to eliminate double-entry of data is important, especially in a fast-paced world.  So, having the ability to launch a Corrective Action directly from the adverse event record is critically important.  Not only does it elminate the double-entry from one process to the next, but it also provides a well-defined link from the source event to the Corrective Action.  This way, you can trace the process from discovery, to investigation, to correction to resolution...in one continuous trail.

2.  Tactical Usage of Risk to filter Events:  We talk plenty about Risk Management and Risk Assessment, but the reality is that companies need to have both a strategic purpose for Risk as well as a tactical purpose.  Tactically speaking, if you are collecting adverse event data, you want to be able to filter these events in a systematic and logical way.  Focusing on the events with the highest risk makes perfect sense when you are trying to stay in compliance.  Companies, especially those in Life Science, are taking their adverse event and building out risk matrices that help them determine the next course of action.  This will give them guidance on whether Corrective Action is needed, recall is required, or immediate correction is all you need.

3.  Process-Based Audits:  Auditing is a time consuming process, and many organizations devote an entire department to auditing.  When you factor in compliance and regulatory oversight, the internal auditing function is your assurance that when you get visited by the FDA or other bodies, you have crossed your "t's" and dotted those "i's".  However, there is a growing shift from auditing by department or operational area to auditing by business process.  Many times a department will have overlapping processes, so if you're auditing from one department to the next, it is very likely you may audit the same exact process several times.  This is inefficient in concept, and organizations are trying to look at business processes first and audit based on those criteria.  That way, the processes you audit will cross over departmental and operational areas, and you are not double (or triple) auditing.

4.  Integration is Important, but Shouldn't be Complicated:  Integrating business systems is key to connecting multiple areas in the business.  However, it often can be complicated to achieve the integration functionality to do everything the organization needs it to do.  We are seeing a trend of implementing simpler methods of integration, and focusing on core requirements of integration, and not pulling all the "bells and whistles" with custom-developed, involved integration methods.  Tools that provide simple means to link databases and pull/push information are evolving to not only make integration more accessible, but do so in a way that empowers business users to leverage integration.

5.  Visibility into Trending is "Trending":  This is nothing particularly new, but we know that with all the data coming into the systems, whether Quality Management or others, it overwhelming.  Having robust reporting that makes sense of the data is key to success.  But it's not just pulling reports;  it's about generating alerts when unfavorable trends occur, or having data pushed to mobile devices.  Reporting is now more of a real-time feed on the health of the Quality Management System.  Organizations need to be able to quickly find the data, analyze and trend out what's going on.  This is becoming more and more important, and companies are spending as much, if not more time on their reports as their business processes.

These are just a few trends we've seen pop up over the past few years.  Companies like LNS Research are taking it a step forward and really honing in on customer needs and industry trending and communicating where the next innovations will be.  Join us next week, and get some insight into what's trending with respect to Quality, Risk and Compliance within Life Sciences.

Free Webinar
Integrating Risk and Quality Management in Life Sciences May 23, 2013 | 1pm ET

In this webinar, Matthew Littlefield from LNS Research will conduct a deep dive on the role of risk and compliance in quality management, providing benchmark research from a recent LNS Research study of over 100 life sciences companies, including the best practices for managing risk and compliance, how compliance fits into the global quality management strategy, compliance challenges facing executives, and much more.

Register for This Webinar Now!

Related Topics:
Steps to Building a Risk Management System: Influencing Compliance
Using Bowtie Risk Management in Compliance Management Systems
The Risk and Compliance Paradigm: Risk Management's Impact on QMS

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).

On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.

UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products.

The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.

The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.

The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.

Risk of serious or life-threatening allergic reaction.

These products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.