Rupa Mahanti’s default image

By: Rupa Mahanti

We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount of data coming in, it’s important to know what is “quality” data, and what isn’t.

Data entities, elements, dimensions... oh my!

Before we continue, let me explain a little data terminology as it pertains to databases, or data storage. “Data entities” are the real-world objects, concepts, events, and phenomena about which we collect data. “Data elements” are the different attributes that describe the data entity. Thus, a data entity serves as the container that comprises all the data elements that describe it.

Consider a machine shop that has many types of machines: CNCs, lathes, presses, and the like. A “machine” would be the data entity representing a physical object sitting on the shop floor, and the data elements might be machine type (e.g., CNC), machine ID, machine name, machine make, machine location, machine uptime, and so forth, which store attribute values for the different machines.

Multiple Authors
By: Sheng Lin-Gibson, Vijay Srinivasan

Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore, controlling and maintaining quality remains a challenge. The potential for new therapeutics to cure and treat previously untreatable diseases is enormous, but there is still a long way to go before they can be manufactured at the required scale, with predictive control of quality, and at a lower cost. NIST’s Vijay Srinivasan and Sheng Lin-Gibson discuss their recent paper on some of the challenges and solutions associated with manufacturing these life-saving drugs.

Randall Goodden’s picture

By: Randall Goodden

The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are primarily focused on marketing their new products, increasing sales, and hopefully, ensuring their products are safe and will live up to expectation.

But with all the records being set in the stock market and employment, record numbers of product recalls and product liability lawsuits are also happening. What further compounds that problem are executive management teams making assumptions that their employees know how to prevent product recalls and product liability lawsuits, that it’s basically “common sense.” This false perception has led to an ever-growing trend in product recalls, record-breaking numbers of product-liability lawsuits, and manufacturing corporations going bankrupt.

Quality Digest’s default image

By: Quality Digest

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this year was no different.

Below are five articles that garnered a lot of interest from our readers. As you can see, the topics are quite diverse.

Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
by Kelly Kuchinski

The QA Pharm’s picture

By: The QA Pharm

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all 11 quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

 

Heather Thompson’s picture

By: Heather Thompson

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

Medical device companies developing these products can take advantage of the FDA’s new programs designed to advance trusted companies so they can get products to market efficiently and effectively.

Equally important, if you want to be part of the SaMD trend and its accompanying regulatory pathway, the FDA is clear: Make sure your quality management system (QMS) is exemplary.

Dileep Thatte’s picture

By: Dileep Thatte

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12 months. These statistics are important to take note of and address because the U.S. food supply also represents a huge economic asset, contributing almost $1 trillion to the national gross domestic product (GDP) each year.

Boris Liedtke’s picture

By: Boris Liedtke

In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German pharmaceutical giant Bayer, over its decades-old product.

A judge slashed the award to $86.7 million in July 2019 after Bayer appealed, but it is cold comfort for the company. An estimated 13,400 similar Roundup cancer cases are pending in state and federal courts across the United States. European investors and Bayer’s management are in shock at the size of the settlements.

Steven Brand’s picture

By: Steven Brand

The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers. And they’re not just demanding it; they’re “voting with their dollars,” supporting companies that align with their personal beliefs. To keep up with consumer demand—and to keep up your bottom line—it’s important to understand their needs and make changes that support them.

In doing so, you can improve your product quality, reduce waste, inspire brand loyalty, compete more effectively, and avert potential media or food-safety disasters. Let’s look at six ways to improve product quality in food manufacturing.

Peter Rose’s picture

By: Peter Rose

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and be fully compliant under EU MDR.

This statement alone may be surprising to certain Class I manufacturers, who assume that their products’ classification as low-risk devices under the previous directive will exempt them from all this EU MDR commotion. These presumptions are misguided because classification requirements listed in the EU MDR are relevant to all manufacturers, irrespective of past classification.

With this deadline in sight, it is crucial that all manufacturers familiarize themselves with these regulatory changes and promptly make a start on implementing necessary measures. Those that fail to achieve compliance on time will be left behind, and their products removed from the market. In light of this industry bustle, this article aims to advise Class I manufacturers about the primary alterations that the EU MDR will enforce, as well as offer practical steps that manufacturers can begin to follow.

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