FDA Compliance Features

Quality Transformation With David Schwinn's picture
Quality Transformation With David Schwinn
“Under-promise, over-deliver” is a phrase taught to me many years ago by my friend and colleague, PQ Systems’ owner Michael J. Cleary. It may have always been true. It may always be true. It is...
The QA Pharm's picture
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...
Lisa Lupo's picture
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...
Danita Johnson Hughes Ph.D.'s picture
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....
TraceGains's picture
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,...
TraceGains's picture
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,...
The QA Pharm's picture
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,...
The QA Pharm's picture
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,...
Bruce McDuffee's picture
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...
Kimberly Egan's picture
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...
Ryan E. Day's picture
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...
Anonymous's picture
Claire McKenna
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...
Pierre Huot's picture
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...
The QA Pharm's picture
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...
Dirk Dusharme @ Quality Digest's picture
Dirk Dusharme @ Quality Digest
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...
The QA Pharm's picture
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:...
Taran March @ Quality Digest's picture
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...
Anonymous's picture
Chris Draska
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...
Anonymous's picture
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...
Environmental Quality Corner with Ken Appel's picture
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...