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 News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials

FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials

March 3, 2017

Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances.

The draft question and answer guidance covers the implementation of a single section of the Q11 manufacturing guideline — first developed by the International Council for Harmonisation and adopted by the FDA in 2012 — and makes recommendations for the information that should be included in marketing applications.

The guidance makes it clear that the term “starting material,” as described in the Q11 guideline, is the same as the “API starting material” referenced in the ICH’s separate Q7 guideline covering good manufacturing processes.

All principles in the Q11 guideline should be considered, instead of simply using a selection to justify starting materials. If a material does not meet all the principles, applicants should provide a rationale explaining why the material is still appropriate.

Post-approval changes to steps prior to starting materials are not explicitly covered in ICH Q11, and changes prior to starting materials should be evaluated for their impact on current and potential new impurities. Additionally, the general principles of the Q11 guideline apply independently to the selection of starting materials for linear and convergent syntheses.

The Q&A also defined the difference between a commercially available chemical and a custom synthesized chemical — the former is one sold as a commodity in a non-pharmaceutical market, while custom synthesized chemicals are generally understood to be made specifically to a drugmakers’ requirements, the document said.

The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Order the webinar CD Five Case Studies Using the E2500 Approach to Validate Equipment, Utilities and Facilities today and gain a clear understanding of FDA inspector expectations and how to meet those expectations for equipment, utilities and facilities validation.

View today's stories

Drugs Regulatory Affairs

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 07Dec

      Proactive Supplier Management Using Quality Agreements

    • 13Dec

      FDA Inspection Overhaul: How Things Have Changed in 2023

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • T-cell Malignancy From CAR-T Cell Immunotherapies Gets FDA Investigation

    • Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

    • Novo Nordisk Battles Wegovy/Ozempic Pretenders and Faces Mounjaro’s Superior Study Results

    • Social, Emotional Risks Associated With Multi-Cancer Screening Discussed by Adcomm

    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