All Features
The QA Pharm
A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in fact no testing was done—among other issues.
The FDA rather understatedly informed Ningbo Smart, “…
Lisa Lupo
Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management. When an audited company continues to show a flawless record for, say, a food-safety audit, chances are it…
Danita Johnson Hughes Ph.D.
Read this. It won’t be a waste of time.
Time gets lost. People kill time. Time flies. It gets wasted. Time weighs heavy on our hands. We spend time. Time passes. It drags on or it hurries by. Those behind bars are said to be doing time. Sometimes, we have no time left; we’re out of time.…
TraceGains
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…
TraceGains
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…
Bruce McDuffee
If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (…
Kimberly Egan
It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly. The federal government recently “identified a mother lode of government waste and duplication” and decided that getting rid of it “could potentially save billions of tax dollars annually…
Ryan E. Day
The recent brouhaha involving a class-action suit against Taco Bell alleging that their beef filling is more filling than beef really got me thinking, but not about what’s in the tacos. Instead, it got me thinking about quality control, quality assurance, and particularly about customer…
In business there’s a saying: Time is money. The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realize significant cost savings and also get their products into the market faster…
Pierre Huot
If a manufacturer were to ask its clients how they evaluated goods or services, the three most common metrics would be goods at a fair price, on-time delivery, and quality. Ask which could be most valuable and in all likelihood the most significant response would be quality. When included in the…
The QA Pharm
Most pharmaceutical companies have an internal current good manufacturing practices’ (CGMP) auditing program administered at the site and corporate levels of the organization. Auditors are typically part of the quality assurance or regulatory compliance function, and the usual approach is to…
Georgia Institute of Technology
Researchers from the Georgia Institute of Technology have created a new sampling device that could prevent thousands of people worldwide from dying of pneumonia each year.
Called PneumoniaCheck, the device created at Georgia Tech, is a solution to the problem of diagnosing pneumonia, which is a…
Claudia Jackson
Twitter is not at all what I expected. After a few months, I now use Twitter to improve my knowledge in health care quality, expand my professional network, and save time. Through Twitter, I’ve connected with an amazing variety of people, including health care providers, marketing pros, e-patients…
Barbara A. Cleary
A young man in PQ Systems' hometown survived a dramatic auto accident last summer in which police-captured video footage of his spectacular, airborne vehicle was broadcast throughout the nation. That was just the beginning of his problems, for during his hospitalization, his medical records were…
Dirk Dusharme
For most of us, food safety is a topic that, at best, only lurks at the edges of our brains. It rarely becomes something we really think about until we open up our refrigerator and try to figure out what’s growing in the back corner of the bottom shelf, or until we hear stories about people being…
The QA Pharm
People often ask me how best to prepare for a Food and Drug Administration (FDA) inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me; that is a huge first step. Just like Alcoholics…
Taran March @ Quality Digest
Pharmaceutical manufacturer Johnson & Johnson, which for decades has enjoyed a trusted reputation for soothing babies and overcoming head colds, is currently facing criminal investigation by the U.S. Food and Drug Administration (FDA). The company’s McNeil Consumer Healthcare unit closed a…
Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around…
A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.
With this in mind, the editors of…
Environmental Quality Corner with Ken Appel
Ken Appel is the manager of regulated industries for Veriteq.
In part 1 of this article, we discussed the pros and cons of various systems for stand-alone monitoring instruments (e.g., chart recorders and data loggers) and wired networks, with and without power over Ethernet (POE). In the…
Environmental Quality Corner with Ken Appel
Ken Appel is the manager of regulated industries for Veriteq.
T
he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help…
Thomas R. Cutler
Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…
The QA Pharm
My definition of “specification” is rather simple: It’s a promise.
Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less…