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.
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 programmers who analyze clinical trial data in the pharmaceutical and biotechnology industries, the Standard Data Tabulation Model (SDTM) is incredibly important and valuable. Prepared by the Submission Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC), the purpose of SDTM is to organize, structure and format standard clinical trial tabulation datasets submitted to regulatory authorities such as the US Food and Drug Administration (FDA).
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.
Given the lightning pace of business at medical device, pharmaceutical, and biotechnology firms these days, it’s no wonder that more and more companies seek talented, experienced consultants who can quickly ramp up to work on critical projects. EG Life Sciences partners with life sciences companies to locate top talent to meet this demand and works closely with consultants to match them to these opportunities.
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.
In Deloitte’s 2016 Global Life Sciences Sector Outlook, the research points to “an ever-evolving regulatory and risk environment” coupled with the “growing prevalence of chronic diseases” as just two of the factors driving the growth of the biotech sector and the heightened need for skilled Life Sciences professionals.
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.