New and Revised Draft GMP Guidances FDA is planning to publish 2017

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has published a Guidance Agenda with planned new and revised Draft Guidances for the calendar year 2017. Amongst these documents are a few which might be interesting for the GMP area, for example:

• Bioanalytical Method Validation; Revised Draft
• Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft
• Drug Master Files; Revised Draft
• Visual Inspection of Injectable Drug Products
• Current Good Manufacturing Practice for Medical Gases; Revised Draft
• Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
• Field Alert Report Submission
• Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities

The items of the Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 reflect draft and revised draft guidances under development as of the date of FDA's posting. So there might be more to come.