When the FDA inspects 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 might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.
In our recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team 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.
Don't limit your team's ability to perform. Consider freeing up your best internal resources by using an outsourced team as an extension of your functional group.
It’s certainly a challenge that most – if not all – companies face these days: which aspects of our business do we keep in-house, and which pieces do we outsource? And nowhere is that more of a challenge than within the regulated environment of the pharmaceutical industry.
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.
WHAT IS IT?
The European Union put a new MDR, or Medical Devices Regulation, into effect on May 25, 2017. The MDR replaces both the former Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation has a transition period of three years, during which time manufacturers are expected to revise their internal production processes and related technical documentation to align with the new requirements put into effect by the MDR.1,2 Ideally, the replacement of the MDD with the MDR will encourage a greater universal compliance to stricter standards throughout Europe of regulations related to medical devices.
Biopharma advancement is at an all-time high with breakthrough drugs and life-sustaining therapeutic treatments being developed, manufactured, and approved every day. It’s a space of incredible growth but also one that’s heavily regulated by the FDA and other global regulatory agencies. Lately, there have been so many new products showing great promise and thus scaled up from Clinical Phase 1 through Late Phase Clinical II/III up to commercial launch. Clearly, there is a vast amount of work and resources required to support this growth curve. This post introduces key topics that impact the overall product lifecycle; during the coming weeks, we will subsequently break them down into tangible, action-oriented recommendations for success!
In today’s world, clinical trials are expensive, complex, multi-disciplinary processes involving multiple partner entities working together to satisfy stringent regulations to improve patient lives by bringing innovative therapy to the market. Due to the competitive nature of our industry, there is a push towards increasing efficiency in order to deliver an on-time, on-budget accurate representation of clinical trial data to regulatory authorities.
The total error approach is a statistical technique for assessing performance of analytical methods. It could be used for any lab data analysis in oncology or other clinical trials or for the testing of new drugs. Due to variable parameters involved in inter-laboratory transfer of clinical trials like analysts, instruments, day/sessions and geographic location, there are chances of different assignable and non-assignable causes of variations. Here, the statistical analysis of measurement processes helps to identify and quantify sources of variation. The total error approach evaluates the variability in the parameters and helps the scientist in decision making.
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.
How do we extract the right data to tell the most important stories and then present them to others in a way that can make a difference for clinicians and patients? This question is truly at the heart of data visualization. In this paper, Data Visualization: The Epilepsy Story, we aim to do just that; we tell the story of epilepsy based upon the exploratory analysis and visualization of data for clarity.