On April 4th, 2017, EG Life Sciences will host a breakfast event at MassBio that will feature Gary C. du Moulin, Ph.D., M.P.H., RAC who will present "Core Components for Contamination Prevention and Control in Biopharmaceutical Manufacturing Operations." Gary recently retired as Senior Director of Quality Aseptic Control for Genzyme (a Sanofi company) where he participated in the development and execution of robust quality systems for Genzyme's products including biologics and cell based therapies.
California and Massachusetts are always mentioned together when speaking about the leading life sciences clusters in the US. They frequently share the number one and number two spots on the many lists that are published in the scientific community. The reason? The abundance of world class educational institutions in these areas give companies easy access to top level talent.
What is a Pre-Approval Inspection? For pharmaceutical companies, this FDA inspection is intended to determine whether their facilities, manufacturing processes and controls used to produce and package drug products are adequate to ensure the safety and quality of their products. The FDA wants assurance that problems that arise during the drug manufacturing process are investigated properly and that quality systems are in place to document and remediate these issues in a timely manner.
In my recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team on hand that is always “at the ready” for FDA visits, regardless of whether the visits are scheduled or unannounced. But what happens once the inspectors arrive? You should have a checklist on-hand for the key logistical considerations.
For pharmaceutical, medical device and biotech companies, being always “at the ready” for FDA inspections is an absolute necessity. While some inspections are predetermined, others are surprise visits so it’s critical to have a team and a process in place to ensure you can respond to every inquiry effectively.
When the FDA comes in to inspect a pharmaceutical or biotechnology company’s manufacturing facilities they can either alert the company ahead of time or show up unannounced. After the inspection is over the FDA can send what is called an FDA form 483 or a warning letter. There are differences and various consequences depending on how these are both handled.
The Life Sciences industry is one of the most rewarding and exciting industries to be involved in. It gives people a great sense of accomplishment when their contributions assist those who must manage or overcome a debilitating disease. It takes years of research, development and testing – and billions of dollars - to bring just one drug to market. In addition, the amount of information that is compiled and tracked is enormous and great care and accuracy must be taken to ensure its accuracy. That is why it is always frustrating and concerning to hear about drug firms that intentionally falsify data and records to manipulate results into looking great when in reality they tell a different story.
When biotechnology drugs are produced they require very specialized equipment during the manufacturing process. Traditionally this would include equipment such as stainless steel bioreactors and stationary protein purification chromatography columns. A growing number of well-known biotech firms are adopting what is referred to as single-use disposable technology. This technology allows its user to dispose of it after a certain step in the manufacturing process is complete.
In the ever evolving world of Biotech and Pharma there is a myriad of information that needs to be compiled and shared between different functional groups in an organization. This includes regulatory, manufacturing, and compliance information. Usually this information is stored in separate and often disparate electronic systems, and this data is often requested by regulatory agencies such as the FDA when they conduct inspections to approve new drugs. What if this information was available using a single system?