The FDA’s New Inspection Practices: A Guide for Drugmakers

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The FDA’s New Inspection Practices
A Guide for Drugmakers

The FDA is changing the way it handles inspections.  Even if you passed an inspection before, new requirements — and new inspection practices — can leave you exposed to enforcement.

Under the FDA’s new inspectorate reorganization, the agency will send a team of highly trained and specialized investigators to your facility. These investigators will be experts in the specific manufacturing processes you use and they will know exactly where to look for and find problems.

The FDA’s New Inspection Practices: A Guide for Drugmakers explains the FDA’s plans for upgrading its inspectorate and provides the key resources you will need to prepare for your next inspection. You’ll learn:

  • How each of the three ORA inspectorate programs — pharmaceutical quality, biological products and bioresearch monitoring — will be reorganized
  • The latest resources FDA investigators use to train and prepare for inspections
  • The top 483 citations in 2016 — a roadmap to what investigators are looking for!

The guide includes the following resources:

  • The drug and biologics centers’ plans for organizing and training their investigator corps;
  • FDA Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
  • CPG 7345.848 — Inspection of Biological Drug Products
  • CPG 7346.832 — Pre-Approval Inspections
  • CPG 7356.002 — Drug Manufacturing Inspections — Newly Revised
  • CPG 7356.002F — API Process Inspection — Newly Revised
  • CPG 7356.002B — Drug Repackagers and Relabelers — Newly Revised
  • CPG 7356.002M — Inspections of Licensed Biological Therapeutic Drug Products — Newly Revised
  • FMD 145 — Release of Establishment Inspection Reports
  • FMD 86 — Establishment Inspection Report Conclusions and Decisions
  • Sample forms and program maps

Get ready for your next inspection and understand the newly revised procedures — guidances, compliance program guides, field management directives — with The FDA’s New Inspection Practices.

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Table of Contents

  • Introduction
  • The Shape of Inspections to Come
  • FDA Program Alignment Plans
  • Resources
  • And More …

View the entire TOC

Who Will Benefit

  • Quality manager
  • Senior staff
  • Line supervisors
  • Legal counsel

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