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 » EC Guideline Clarifies Role of Qualified Persons in Global Drug Manufacturing

EC Guideline Clarifies Role of Qualified Persons in Global Drug Manufacturing

November 19, 2015

The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect.

Among key changes, the guideline increases documentation of the supply chain for active pharmaceutical ingredients and requires drugmakers to have documented evidence ensuring the integrity of imported batches.

At third-country manufacturing sites, sampling should include a quality risk management plan, as well as an audit of the manufacturing and sampling activity at the third-country site.

QPs also need to describe the sampling process in the third country and the transported conditions of the sample and the imported batch, justifying any differences. A comparative analysis of samples taken in the third country and samples taken after importation also needs to be performed, taking into account the time difference between sampling and importation.

The guideline incorporates recommendations of three ICH standards: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality systems.

The guideline — Annex 16: Certification by a Qualified Person and Batch Release — also details tasks that can be delegated to trained staff or third parties, such as ensuring that audits of manufacturing sites have been conducted and that appropriate arrangements for distribution and shipment are in place.

Robert Schiff, president and CEO of Schiff and Company, notes that for drugs to be released in the EU, the QP must be based there. That has implications for foreign multinationals, he says, noting an Indian drugmaker would need to have an EU-based QP to sell its product on the continent.

The guideline, which revises a July 2001 version, takes effect next April.

Get the last word on current regulations, guidelines, and auditing standards for APIs in our book Drugmakers’ Guide to Global Quality API Manufacturing. You’ll discover clear plain-English explanations of dozens of pressing manufacturing quality issues, including how regulators in various countries define APIs, how to prepare for and conduct audits of API suppliers and much more.

Pharmaceuticals Regulatory Affairs GMPs

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

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

  • MicroPort Navibot Receives 510(k) Clearance for Its SkyWalker System

  • FDA Expands Approval of Pfizer and Myovant’s Myfembree to Include Endometriosis

  • FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers

  • FDA Issues EUA for Monkeypox Vaccine

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing