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Global Audits Blog
by Bob Lucchesi Welcome to my first in a series of auditing blogs. I hope you find them interesting, useful, and sometimes entertaining, because if you are like me, I am bombarded with information surrounding the Life Sciences industry and I am always seeking relevant information to aid in my career. First, allow me to introduce myself. I am a long-time consultant who has spent the majority of his life helping customers with a variety of both complicated and not-so-complicated problems and issues in the areas of compliance, regulatory, validation, and all things Pharmaceutical, Medical Device, and Biotech. I also play…
With internal audits you want to audit to particular regulations. If you are under International Organization for Standardization (ISO) or Good Manufacturing Practices (GMP) constraints you want to make sure you are touching on any regulatory or compliance issues that a costumer, the Food and Drug Administration (FDA), or any other international agency is going to look at. That being said, it is also very important to concentrate on other areas as well as it comes down to best practices. You should look at your controls in place for everything from training records to manufacturing plans to organization and how…
In many cases we see that individuals involved in assisting with remediation have their own normal day jobs along with other duties and responsibilities. These individuals are often pulled into the project in a matrix type of organization. It is very important that commitments are obtained with the resources from the internal organization. It is important to realistically commit a resource’s time. In order to support the remediation plan, which is the top priority, we recommend the organization bring in some extra contract support. This additional support will help manage some of the day-to-day duties and offload work normally completed…
You do not need to communicate other areas of remediation to the FDA immediately. For instance, if you have a nine month plan and a couple months into it you find an area that you need to correct and a couple months after you find another area that you will remediate that wasn’t part of an initial finding either, you do not have to communicate all of that back to the FDA. But, in your final report or your final statement back to the FDA you may want to include that information. Including your own findings shows that you are…
In order to determine the rank of a supplier it is important to take the risk-based approach. The FDA really promotes that as well as what they call “the least burdensome process”. Whether it is supplier qualification, computer system validation, cleaning validation, or process validation it is essential to take that risk based approach. Evaluate the risk to the product, the risk to patient safety, and the safety's quality, identity, purity, and potency. For example, a supplier of glass vials you will use for the final packaging of your biologics product is a much greater risk than the supplier doing…
We can all estimate times and we have all been through projects that don’t end on the date or time expected. As long as you communicate, you will be fine. If you have committed to a particular date on your 30-day response to a warning letter and you find that while you are remediating you need more time, you must communicate to the FDA. It’s not uncommon to have an initial timeline in place and then find you need additional time. You will be fine as long as you explain why you need more time, what the new time frame…
It certainly is acceptable to push back, but you need to be able to do that in a professional and politically correct manner. The best way to do that is to push back during the course of the audit or while the inspection is still in progress. If the investigator indicates that he or she has a particular concern, it is important to first understand their concerns, make sure they are not misinterpreting your quality system or your process or procedure, and make sure you have presented all your appropriate artifacts and objective evidence. USDM does this during readiness assessments…
If staff members are performing standard of care tasks, such as vitals they need protocol specific training if the task is part of a protocol specific procedure.  There could be protocol specific requirements.  For example, clinics and hospitals have a standard of care practice for performing vital signs.  Protocols also have a specific requirement at times when performing vital signs, such as the subject may need to be seated for 10 minutes, utilizing a non-dominant arm, capturing the vital signs in duplicate with two minutes of separation are not Standard of Care.  Depending on the protocol and the study requirements,…
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