FDA Inspections

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  • Hosting FDA Inspections
    This article, written by a former GMP Institute senior consultant with many years of field experience, tells you how to prepare for an FDA inspection so that it will go as smoothly as possible.  It is a valuable tool for anyone who is involved in dealing with an inspection, from the front desk person to senior management. 
  • What Should I Expect During An Inspection? This page provides FDA's brief overview of what happens during an inspection. 
  • Investigations Operations Manual
    The Investigations Operations Manual (IOM) is the primary source of guidance regarding Agency policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities.  As such, it can be very helpful for life science professionals, as it is a good tool to learn what to expect from FDA. 
  • Inspectional References
    This page presents information provided to FDA investigators and inspectors to assist them in their daily activities.  Some references included are:  Field Management Directives, Guides to Inspections, Investigations Operations Manual, Inspection Technical References, Medical Device GMP Reference Information, and QS Regulation/Design Controls. 
  • Quality Systems Inspections 
  • Technique (QSIT)
    This document was developed by FDA to create an inspection program covering the quality systems regulation, which results in more focused and efficient inspections. It helps FDA investigators focus in on key manufacturing and quality areas at the manufacturer during inspections, in order to determine their state of compliance with the Quality Systems Regulation.
  • Compliance Program Guidance Manual:  Inspection of  Medical Devices; Final Guidance For FDA and Industry  
    This guidance document represents FDA's current thinking on the enforcement of the Quality System/Good Manufacturing Practices (QS/GMP), Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals (CAR), and the Registration and Listing Regulations. 
  • Compliance Program Guidance Manual For FDA Staff: Drug Manufacturing Inspections
    This compliance program is designed to provide guidance for evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
Last Update: 19 September 2011

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