Knowledge Center

When FDA recommends a consultant

As a regulatory agency, the FDA expects that organizations that they audit will take appropriate measures to ensure that they remain in compliance with the regulations. In the event that the FDA determines that a particular organization consistently gets reprimanded for non-compliance, they will likely look into the Quality System of the organization to make recommendations to amend the ongoing problems that the FDA has noted. Most of the FDA audit observations that I have seen are circled around the

FDA Audits .. Are You Ready?

As we all know, FDA audit observations and warning letters can be costly to the existence of a company, and it is in the best interest of a company to comply and correct any discrepancies in a timely manner. The best way for a company to deal with any observations or warnings is to correct them promptly. However, by being prepared for inspections, a company can avoid having to scramble to meet deadlines for correcting findings, even if there are

Warning Letters and your commitment to the FDA

According to the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374), the FDA is authorized to perform inspections on a regulated premises. Any compliance concerns or discrepancies are addressed by the FDA inspectors via form FD-483 or Warning Letter. It is in the best interest of the organization to respond to observations and findings in a satisfactory manner, in order to avoid the FDA taking further adversary actions against the organization. A well organized, well documented, and timely

Two different organization cultures

The essence of a society is found within its culture. This culture is deeply engrained within each individual, and cannot be changed by merely manipulating superficial policies & procedures. When change is needed, it is the leaders of a society who must pioneer changes. Leaders will determine the morale of their people, and it is the leaders who will ultimately determine a society’s attitude toward problem solving. As with any industry, pharmaceutical companies must regularly deal with a vast array of

A Tale of Two Deviations

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s). After all, to maintain a good compliance profile, as well as an efficient operation, requires the ability to detect problems, determine the root cause and permanently eliminate the problems.Good companies are glad that a problem was detected and reward the one who detected it. It’s another opportunity to improve—one more problem that they never have to

Are Commitments Made to FDA to be Taken Seriously?

Responses to FD483’s and Warning Letters are usually fully of commitments. They involve “what” will be done to correct compliance problems, and “when” it will be done. FDA has even started to ask “how” they will be done, meaning—Do you have the resources to do the work? If these questions are not fully addressed in the FD483, then FDA asks again in the subsequent Warning Letter in the part where they acknowledge receipt of the firm’s FD483 response—and the inadequacy of

Company Culture and CGMP Compliance

I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation as anything else. I have divided companies with significant regulatory issues into two categories: those who seriously strive to make the connection between the purpose and intent of the regulations and weave it into their

Current Pharmaceutical Industry CGMP Compliance Trends

It must be that time of year again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry. So with this edition I offer my opinion not only to those conference planners, but also to my readers. After all, why should you—my loyal readers—have to attend a pricey conference to hear what I told them? But first, a note about—well, these

Data Talk – Opinions Walk: Justification vs. Rationalization

I was a judge for a junior high school science fair where young minds applied the scientific method to everything from bean sprouts to producing amino acids from primordial ooze. It was great to see creative minds at work as each explained their hypothesis, methods of observation, data collection and conclusions. Of course, I took the opportunity to explain to each how their scientific skills would be of tremendous importance in helping sick people get better in the exciting industry of

FDA Inspections

I am often asked how best to prepare for an 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 AA’s 12 step program, it’s not until you are willing to admit this aloud that you are on the road to recovery. But just knowing that problems exist is not enough to survive an