Consent Decrees—When the FDA Gets Tired of TalkingCompanies are much better off overseeing their own compliance to regulations
Tue, 03/22/2011 - 08:08
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’… Internal Quality Audits: Valuable or False Security?Only when the “auditor” supports the “owner” by assessing whether the “ownership behaviors” are effective
Tue, 02/08/2011 - 04:30
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… Who Owns the Quality System?When ownership behaviors are expected and nurtured, awesome things happen.
Wed, 01/05/2011 - 07:43
I
understand on a philosophical level that everyone owns “quality.” Much like safety, everyone has responsibility for following safe practices and calling attention to potentially unsafe conditions. However, there are also safety departments… FDA Inspections: When You Know You Have ProblemsChoose your spot on the slippery slope
Wed, 12/15/2010 - 05:00
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;… When All Else Fails, Lower Your StandardsThis seems to be the thinking for two pharmaceutical manufacturers
Fri, 11/05/2010 - 09:41
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.… A Cure for Customer-Activated Tone DeafnessThe best-of-the-best companies have complete transparency to customer complaints at the most senior level
Thu, 10/07/2010 - 05:30
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.
Many pharmaceutical companies embed their high… Quality Assurance: To Count the Cost—or Not?The price of nonconformity should always be accounted
Wed, 08/18/2010 - 14:15
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 assurance (QA) career, it was impressed upon me to not…
