Want to see what MasterControl has done for great organizations? Explore our many case studies. We are growing fast and looking for innovative and creative people to join the team. Learn about the variety of partnerships and strategic benefits available in our partner network. QSIT Quality System Inspection Technique is the name of the document that provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer's compliance with quality system regulations.
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Fall within these bounds, and you can anticipate an FDA inspection at your facility. For the scope of this article, though, we will focus specifically on the inspection of medical device manufacturers. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.
Pre-Approval Inspections are conducted after a company submits an application to FDA to market a new product. These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product. The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval.
A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action. The source of the report can be the manufacturer e. These inspections typically are more in-depth than routine inspections, and they may not follow a QSIT approach.
Will you know when FDA is coming? It depends. Firms with a history of violative inspections will not be granted this luxury, and FDA may show up unannounced. FDA inspection of a foreign establishment typically is preannounced two to three months in advance to allow time for travel and scheduling logistics.
Ever wonder how FDA chooses which firms should be selected for a routine inspection? FDA uses a risk-based approach. The Device Listing database is used to identify which devices each firm distributes. Firms that have recently introduced a new device to the market also are given higher priority, as well as those that have had significant prior violations and complaints.
The majority of inspections are routine inspections. It evaluates and describes the purpose and importance of each subsystem, providing flowcharts and inspectional objectives for each subsystem. It is conducted when a firm has never had a Level 2 inspection, and every six years thereafter. It provides an overall evaluation of the quality system. A Level 1 Abbreviated QSIT inspection is conducted after a firm has had a Level 2 inspection, and the quality system was found to be in compliance with all requirements.
A different subsystem will be chosen for each subsequent Level 1 inspection. Regardless of the type of inspection, it is up to you to always be prepared for FDA to visit your facility.
Understanding the types of inspections and possible inspection locations is just the first step. Make sure to sit down with your team and formulate a concrete plan for inspection readiness. Have a procedure available so employees know what to do and how to conduct themselves when an FDA investigator arrives at your facility. As always, an ounce of preparedness is worth a pound of remediation.
Peter Ohanian joined Halloran Consulting Group in He has more than 35 years of industry experience in medical device quality assurance and regulatory affairs. He has an extensive background establishing compliance programs and developing product clearance strategies.
Prior to joining Halloran, Peter was the Vice President of Quality and Regulatory Affairs for Philips Healthcare, providing leadership and strategic direction for their patient monitoring and clinical informatics business. Get the latest industry news and expert insights delivered straight to your inbox!
Understanding The 4 Types Of FDA Inspection
There are simply too many medical device manufacturers for FDA to inspect annually, so FDA prioritizes its limited inspection staff according to the risk posed by manufacturers and their devices. Some companies get more attention than others. The risk-based approach means companies with new or existing Class III devices are the highest priority, especially those making implantable and life-supporting devices. Class II manufacturers the bulk of the volume are next in line, along with any companies that have recently introduced a device via the k process. Companies that have had their hand slapped in the past tend to get frequent repeat visits, which are often unannounced. Foreign companies typically get more advance notice so that travel and translator arrangements can be made.
U.S. Food and Drug Administration
This one-of-a-kind DVD training tool features a unique insider perspective as Mr. And points out red flags that alert you when an inspector is sniffing for a specific problem. Viewers can clearly identify the key learning points as they are highlighted on screen and elaborated by Tim through his fine-tuned examples, interactive exercises, group discussion and a final exam. In just tightly focused minutes, you and your staff will discover best practices for passing FDA device inspections. Each purchase package includes:. This DVD and related training aids include valuable take-away points and best practices, such as:. Will you pass your next FDA inspection?
QSIT: Quality System Inspection Technique
But what if you're past that point in the process? What if you get a knock on your door and it's a surprise visit from an inspector? As you're probably well aware, the medical device industry is packed with confusing terms and cryptic regulations. Inspectors are required by law to show their credentials upon conduction of an inspection.
The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection