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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Plans to Emphasize Metrics, Not Documentation, in Inspections: CDER Director

FDA Plans to Emphasize Metrics, Not Documentation, in Inspections: CDER Director

November 8, 2013

The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics.

“We really want to know more about the results,” not the design, of a facility’s quality system, CDER Director Janet Woodcock said Nov. 4.

The agency plans to require drug manufacturers to submit data about specific quality metrics within a year or two; it is still deciding what metrics to require, although officials have floated metrics such as batch failure rates or complaint data.

Woodcock, speaking at the 2013 annual meeting of the International Society for Pharmaceutical Engineering (ISPE) in Washington, D.C., said the FDA wants to find metrics that would be appropriate and simple. ISPE is currently conducting a project to solicit feedback from industry on objective and useful metrics. The goal is to develop a white paper that is acceptable to industry and regulators that defines the best metrics for use in a risk-based inspection program.

Woodcock said that many companies already belong to quality organizations such as Six Sigma, and use measures that assess how well they are doing. However, some companies have complained that such measures and metrics are “internal tools” that would be too burdensome for them to report and cause confusion in the marketplace.

The push for quality metrics is tied to legislative mandates in the FDA Safety and Innovation Act to conduct more risk-based inspections. The FDA doesn’t plan to publish quality scores for individual companies, said Woodcock. The goal is to publish “the state of quality of manufacturing in the pharmaceutical industry,” she said.

By publishing an overview of how the industry is doing as a whole, “individual companies can benchmark themselves against that,” Woodcock said. She added that the agency is willing to consider a reward for companies with a good quality record. One such incentive could be more regulatory freedom to operate, Woodcock said, but she declined to elaborate on that concept.

The upside for drugmakers under the risk-based inspection regime is that better-performing companies would face fewer inspections.

The idea of financial incentives for companies that make manufacturing and product quality improvements was floated in a strategic plan to combat drug shortages unveiled last spring. The plan didn’t elaborate on what the incentives could be, and noted that the agency has a limited ability to offer such rewards. 

If you’re still unsure about what the FDA looks for during an inspection, then Investigations Operations Manual 2013 is for you. Order today and find out all the agency’s secrets that you’ve been dying to know.

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing