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
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
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
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...
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...
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
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...
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...
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...
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...
The QA Pharm
We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy...
Sal Lucido
Figure 1: Closed-loop process for managing regulatory compliance
In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-...
The QA Pharm
One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market. When I was first given that responsibility early in my quality...
Environmental Quality Corner with Ken Appel
On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the...
Sal Lucido
In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also...
Oriel STAT A MATRIX
Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented...
Environmental Quality Corner with Ken Appel
For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S. citizens who care about any issue and...
Gene Rider
Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S....
Sal Lucido
The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities,...
Michael Leary
In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are...
