Quality Digest’s picture

By: Quality Digest

Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science organizations can’t thrive.

The following short timeline offers a broad summary of how these elements have interacted during the last several decades. The industry has come a long way.


Thou shalt obey the FDA

The U.S. Food and Drug Administration (FDA) first prescribes current good manufacturing practices (cGMP) requirements for medical devices, including quality management system (QMS) requirements.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

The goal of any honest pharmaceutical company is to make money producing a safe product that consumers need and getting it to market as quickly as possible. But the U.S. Food and Drug Administration’s (FDA) job is to make sure drugs are safe, and that means oversight (some would say excessive oversight), and oversight means costs and delays for manufacturers.

The FDA isn’t blind to this issue. In an October 2005 FDA/ISPE workshop, Dr. Janet Woodcock, director for the FDA Center for Drug Evaluation and Research (CDER) stated that a common goal of industry, consumers, and regulators was to have a “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”1

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By: Laurel Thoennes @ Quality Digest

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and Human Services and broadly spells out the responsibilities for research, enforcement, education, and information

1988: The Prescription Drug Marketing Act
Requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade, or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons

Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.

At J&J, he looked inward, responsible for delivering the strategy and plans for simplifying and standardizing quality systems across the company of 126,000 employees. At Sparta, he looks forward to the future, driving growth strategy, supporting R&D in product development, and influencing how the company’s products and solutions can “participate in the larger IT ecosystem.” McCarthy’s outlook on quality is both deep and broad, and with both types of black belts to his name, he understands the value of practical disciplines. So when he speaks with an evangelist’s enthusiasm about quality management’s role in life sciences, he also promotes a sense of what’s actually possible. The result is a fascinating glimpse around the bend to what lies ahead.

Graham Freeman’s picture

By: Graham Freeman

Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries are frequently the result of fatigue, workplace pressure, and the pressure from extra work due to quality failures.

Among the important elements of people, processes, and tools, people are the primary point of failure in increasingly automated systems. Unlike machines, we are subject to fatigue, information overload, and stress that can have a serious impact on our ability to work safely and efficiently. However, people are also where dynamic sense-making, decision-making, and situational awareness reside, which are vital ingredients in complex and high-reliability organizations (HRO).

The aviation industry represents the best example of an HRO, in which automated systems such as navigation and air traffic control are integrated with highly developed human competencies. As a result, the industry sees an extremely small number of safety violations relative to the millions of hours of commercial aviation operation annually.

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Multiple Authors
By: Manfred Kets de Vries, Katharina Balazs

The global wellness industry is doing superbly, thank you very much. In recent years, it grew a healthy 12.8 percent, becoming a $4.2 trillion market. Whether the lives of wellness consumers are improving at a comparable rate is another matter altogether.

Wellness products and services run the gamut, from vitamins and juice cleanses to upscale wellness studios and spas. At the very end of the spectrum, there are tours positioned as healing and spiritual journeys to the Amazon, where people go in search of psychedelic, hallucinatory insights through sampling ayahuasca, a traditional plant medicine, under the guidance of indigenous or self-styled shamans.

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Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

“GE’s Lessons Won’t Determine Whether You Succeed or Fail”

Does the success or failure of GE’s CEO really matter that much when it comes to how most of us lead, manage, and plan each day? Not necessarily.

“Top Five Things Life Science Companies Need to Know About ISO and FDA Requirements,” an interview with Matthew Lowe of MasterControl.

If the ISO standard says you “shall” do something you should do it; if the FDA says you “shall” do something, you really, really better do it.

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Ryan E. Day’s picture

By: Ryan E. Day

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life science industry, like BBG, operate in a heavily regulated environment. This is the story of how one company delivers world-class products and stays on the right side of compliance while doing it.

BBG’s subsidiaries are:
• Qualtex Laboratories, which provides state-of-the-art patient, donor, and biological testing services. Qualtex has locations in both Texas and Georgia.
• GenCure, which is a human-tissue and cell-therapy organization, collecting and processing human tissues, umbilical cord blood and tissues, as well as providing cell therapy apheresis services, and contract manufacturing services.
• South Texas Blood and Tissue Centers, which provide blood, plasma, platelets, and other blood components to 67 hospitals in 43 South Texas counties.

The fourth arm of BBG is the Blood & Tissue Foundation, which raises awareness and funds to support the many life-saving activities of BioBridge Global.

[Read More]

Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest

These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has kept an eye on the FDA’s progress toward these goals. How well has it done? For a sprawling bureaucracy, marvelously.

One of the first pieces QD published this year was a declaration of intent from FDA chief Scott Gottlieb, who said the agency has recognized “when scientific innovations warrant new, more flexible regulatory approaches.” A number of specific changes that would speed products safely to market have been approved and developed, including harmonizing global standards, supporting electronic submissions, and clarifying and promoting a “least burdensome” approach to premarket reviews. The FDA has also embraced the idea of continuous manufacturing to help drug manufacturers and their customers save money.

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Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell their products in Canada. This mandate could have consequences for Canadian citizens.

What is the Medical Device Single Audit Program?

Is MDSAP one certification accepted by all? No, however it is accepted by five countries: the United States, Canada, Brazil, Australia, and Japan. 

What medical device company that sells internationally wouldn’t want a yearly one-and-done audit that satisfies the regulatory requirements of those five countries? Within the medical device community, where audits are strict and often expensive, the ability to go through a single quality management system (QMS) audit and have those audit results accepted by five countries would theoretically save time and money compared to dealing with each country’s regulations individually. That was the intended goal behind the Medical Device Single Audit Program (MDSAP). However, as is the case with many plans, the unintended consequences may hurt not just the medical device companies it was supposed to help, but in the end may harm consumers.

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