FDA Publishes List of Guidance Documents for 2014

On the quality systems side, the following guidelines are anticipated.  It is interesting to note that there will be guidelines related to Cloud computing as the industry relies more and more on the cloud for data storage and sharing.  The Part 11 considerations can be challenging.

CATEGORY —Quality: Facility, Production and Process Control

  • Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • GXP Consideration for Outsourced IT (Cloud Computing) Systems in Medical Product Manufacturing and Clinical Study Environments
  • Interim Good Manufacturing Practice for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act
  • Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice
  • Submission of Field Alert Reports and Biological Product Deviation Reports

Read: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014


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