Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a day of compliance verification. The most effective way for companies to cope is by standardizing their processes for meeting standards.

There are a lot of processes that need to be standardized. Beyond the common standard operating procedures (SOP), there are protocols to ensure proper setup, operation, and performance of equipment and software. There’s required and verified training for personnel. And there’s setting up restrictions so that only authorized individuals can access a system. All of these processes must be documented, and those documents verified.

Multiple Authors
By: Adrian Hernandez, C. Michael White


he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.

But over the past few years, tens of millions of doses of prescription and over-the-counter drugs have failed FDA quality expectations. This includes the ongoing 2018 recall of thousands of batches of popular blood pressure, diabetes, and acid reflux medications containing the probable carcinogen NDMA.

For perspective, the number of individual tablets and capsules for prescription and over-the-counter drugs entering the United States each year is counted in the trillions.

Del Williams’s picture

By: Del Williams

To meet increasingly strict compliance standards, such as the Food Safety Modernization Act (FSMA) and Global Food Safety Initiative (GFSI), food processors now regularly use adenosine triphosphate (ATP) testing to monitor equipment surfaces for microbial growth. Add to this the need to minimize cross-contamination of products or ingredients with allergens after production changeovers, and more processors are realizing that the traditional cumbersome means of cleaning conveying equipment may not be sufficient to meet today’s rigorous compliance requirements.

When conventional conveyors need to be disassembled, cleaned, and reassembled to reach all exposed internal surfaces, potential downtime can extend to days. If this proves too onerous, some food processors dedicate separate conveyor lines to specific products, which increases capital equipment costs, labor, and the production space required.

Wade Schroeder’s picture

By: Wade Schroeder

Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

If there’s any “spoiler alert” to this article, it’s that human factors, including usability and validation, should not be put off to the last minute. The ultimate goal of early planning for usability testing and validation of your medical device is to ensure you’re building a safe and effective product for the end user.

Early considerations should evolve into formal procedures for usability testing and validation activities that live within your quality system. This will prevent you from needing to scramble last minute or work retroactively once it’s time for your device submission.

This article provides an introductory look at usability testing and validation, and how to build these key components into your quality system.

Introduction to medical device usability

Usability research looks at the interactions between human operators and the medical device. Testing should be conducted on anyone who plays a role in operating the device, from patients to clinicians to people responsible for sterilizing or maintaining the device.

Emily Newton’s picture

By: Emily Newton

Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal. Here’s a look at how such examinations raise food quality and purchaser trust.

Checking foods for pathogens

Food manufacturers engage in microbial testing to look for the presence of viral and bacterial pathogens. Such examinations analyze the food for contamination or possible spoilage.

“Ideally, we want a test method that does not waste time or resources generating false-positive results [i.e., good specificity] while being able to detect even a single viable pathogen in the sample [i.e., high sensitivity],” explains Thomas Jones, a Safe Food Alliance senior director.

A false positive could result in food getting rejected and discarded when there are no genuine issues with it. Conversely, false negatives may mean tainted items reach consumers and make them ill.

Multiple Authors
By: Janet Woodcock, Judy McMeekin

During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health mission while protecting our workforce and the workforces of those we regulate.

Food and medical-product manufacturers of FDA-regulated products generally are required to have a quality management system in place—known in the food industry as preventive controls systems for food safety plans—to ensure that their products are suitable for the U.S. consumer. The FDA conducts inspections to verify that these quality management systems are in place and operating as required, and to note and mandate corrections when they are not functioning appropriately. While onsite inspections represent a key tool, they are one part among multiple components of a comprehensive approach to the oversight of FDA-regulated products.

Esteve Garriga’s picture

By: Esteve Garriga

There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety.

Although current food safety management system (FSMS) certification schemes around the world are highly effective, I believe it’s desirable to have a single agreed-upon FSMS certification that would harmonize various scheme requirements. Such a system would help reduce the auditing burden for companies that are certified to several FSMS schemes.

The most widespread FSMS certification schemes

In 1996, the British Retail Consortium (BRC) was created by UK retailers (Tesco, Asda, Sainsbury’s, and others) to harmonize food safety standards across the supply chain. The first edition of the BRC Global Standard (BRCGS) for Food Safety was issued in 1998, and is now in its eighth edition. Since then, sector-focused standards have been published covering different stages in the food supply chain (e.g., storage and distribution, packaging materials). Today, more than 28,000 sites are operating under such schemes worldwide.

Clare Naden’s picture

By: Clare Naden

Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.

Whether a laboratory develops its own test methods or incorporates ones that already exist, there is a lot to be considered, and the task bequeathed to them is great. Apart from the general risks of contamination, inadequate equipment, or failings in processes that must be rigorously managed, the procedures and tools required for each test can potentially differ.

Since the beginning of the pandemic, ISO has been collaborating with experts in many fields to establish where standards can really make a difference. As a result, experts on ISO’s technical committee for laboratory testing and in vitro diagnostic (IVD) test systems are currently working on international best-practice guidelines to assist laboratories.

Multiple Authors
By: Stephen M. Hahn, Amy P. Abernethy

During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals.

At the U.S. Food and Drug Administration, we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions.

Richard Harpster’s picture

By: Richard Harpster

As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have spent considerable time studying Covid-19 since February 2020. By applying the risk-based thinking techniques I have used, I believe there is a method for saving 100,000 lives before we get the protection the new vaccines are going to provide during the next three or four months.

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