We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA to Tackle Manufacturing Quality Issues Early in Premarket Reviews

FDA to Tackle Manufacturing Quality Issues Early in Premarket Reviews

September 12, 2014

Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line.

Under a new review approach, drugmakers will be assigned a specialized team, rather than a single review official, that will examine the proposed product for potential quality problems, among other things, before companies put in place manufacturing facilities for the drug.

The review team, comprised of FDA experts in drug substances, formulations and manufacturing processes, also will include the investigator who will ultimately inspect the facility for preapproval, giving the company and the investigator an opportunity to work out manufacturing compliance concerns in advance of inspection.

CDER Director Janet Woodcock detailed the new methodology at the 2014 Parenteral Drug Association/FDA Joint Regulatory Conference in Washington, D.C.
The new approach is part of the agency’s ongoing effort to foster a culture of quality in manufacturing facilities.

Woodcock noted that the agency can’t mandate or create such a culture. But she warned that even though manufacturing issues such as long cycle times, poor process capability, high inventories and high waste don’t violate agency regulations, they do have consequences that can lead to substandard products entering the market.

The agency is hoping to take a more proactive approach to identify such problems and help manufacturers prevent them before they affect product quality, Woodcock said. The initiative is currently under development.

Prepare yourself for any premarket reviews the FDA will conduct. Purchase Preparing for an FDA Preapproval Inspection today!

Pharmaceuticals Quality Submissions and Approvals

Upcoming Events

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Issues Update on LivaNova Recall of Blood Pumping System

  • EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis

  • MedTrace Receives U.S. Patent for Heart Modeling Method

  • NICE Recommends Epidyolex for Tuberous Sclerosis Complex Seizures

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing