Knowledge Center

FDA Enforcement Inflation: What’s Next?

I grew up in a home where just a cast of my mother’s glance was enough to cause me to stop dead in my tracks. I knew “the look” quite well. There were no raised voices. When a parent doesn’t follow through on the gentlest of correction, then the parent is communicating that an appropriate response is optional. Out of frustration, parents often up the ante by resorting to yelling and making idle threats. Nothing really changes, because nothing has to.

A case study in CAPA remediation

I was asked by one of my clients to optimize their CAPA process, in preparation for the next FDA inspection occurring at one of their manufacturing sites. The following tasks for this project were required to be completed within a 5- month time frame:a. Review 120 CAPA records,b. Document my review on a remediation form,c. Design and provide training on CAPA and Root Cause Analysis,d. Revise the CAPA procedures,e. Mentor /coach the CAPA leaders, while they worked on remediating the

Good planning can save time

One of my biotechnology clients hired me to conduct a quality system gap assessment. During my first day of work, I participated in a conference call with the top management of the company. The conference call allowed the top management to identify for me which departments were the sources of their business issues, and where I should focus my efforts. They identified the Validation program, the Environmental Monitoring program, and the Laboratory Operations as the root of the problem. They

Top Ten FDA Warning Letter Observations

An anecdotal review of recent FDA warning letters provides key insights to pharmaceutical companies about how they can improve their quality systems, their manufacturing processes and most importantly, manage future FDA inspections. Some surprising information culled from the GMP warning letters issued recently include the following:• Approximately 80 percent of the the FDA-issued GMP warning letters went to domestic facilities, notwithstanding the numerous concerns that have been raised in years past about the increasingly global nature of pharmaceutical manufacturing• A similar

The Most Important Details of a Corrective Action Plan – (CAPA)

Imagine the sheer volume of warning letters the FDA sends out to companies who are not meeting FDA regulations. The companies will no doubt reply back with a presentation to resolve the FDA compliance issues right? With the sheer volume of work involved would the FDA show any remorse for these companies? Generally the answer is no, the FDA’s response would be a fairly “neutral” expression. Now consider for a moment the work involved for the company once they have received one

Consent Decree – why it is so serious?

A Consent Decree takes a tremendous toll on an organization, with a typical decree lasting between 5 to 7 years, and aggregated costs amounting to more than $500 million in fines, penalties, remediation expenses and lost sales. In addition to its major economic impact, consent decrees can severely damage a company’s reputation with both its customer base and patients.By the time a consent decree is in effect, it’s no longer a discussion about responses to Form 483 observations with well-turned

Toward a brave new world of GMP consistency

The New York Attorney General’s sweeping investigation of nutritional supplement manufacturing practices last year sent waves through the supplement and drug manufacturing industries. One solid defense these industries could agree on was ensuring that drug- and supplement-makers fully understood GMP (good manufacturing practices). But understanding GMP and implementing it are two different stages of key practices that make sure products are consistent and safe for customers. Our industries wouldn’t tolerate weighing scales that couldn’t guarantee that 500 mg of ibuprofen was

ISO 13485-2016 .. are you ready for the change?

Is your risk management process ready for ISO 13485? Last year, the International Organization for Standardization (ISO) dramatically revamped its ISO 13485 standard, which sets rules for medical device makers to demonstrate quality control processes and make sure that devices sold to customers are safe and reliable. Certification ensures the ability to sell internationally; losing this certification can sink many businesses. Like most changes in ISO standards, device manufacturers have three years to get certified by the registration agencies. But the new

Sailing through clinical trial audits

The arrival of FDA inspectors to evaluate your clinical trial program (or your CRO’s program) doesn’t have to be a jarring experience. But too often, it is. FDA clinical investigators most often find discrepancies such as: • Not following the investigational plan. • Deviating from the established and approved protocol. • Inadequate record keeping. • Poor accountability of the product (drug or device) under evaluation. • Inadequate participant/subject protection, including no informed consent on file. These problems are all preventable. They can be avoided by diligently

Of Mad Cows and Superior Supplier Quality Audits

In the 1980s, British health and agricultural officials started receiving reports of cows with symptoms of neurological disease. This disease erupted into an epidemic (in Britain) of bovine spongiform encephalitis (BSE), and the scourge of “Mad Cow Disease” was born. The disease, caused by a prion, crossed over to humans to become new variant Creutzfeld Jacob Disease. The diseases, which were often fatal to cows and rarely fatal to humans, were caused by a mis-folded prion protein fragment, and spread