ComplianceOnline

FDA's Guidance on Development and Manufacture of Drug Substances

  • By: Staff Editor
  • Date: May 14, 2017
  • Source: www.fda.gov
Webinar All Access Pass Subscription Abstract:

FDA's Guidance on Development and Manufacture of Drug Substances

The US FDA, in November 2012, has announced its adoption of the ICH Q11 guideline on the development and manufacture of drug substances. The guidance explains both the traditional and enhanced approaches in developing and understanding the manufacturing process for a drug substance. It also offer details on the information that should be provided in Module 3 of the Common Technical Document (CTD) sections.

Bookmark and Share

Trending Compliance Trainings

Trial Master File and Clinical Data Management Regulated by FDA
By - Carolyn Troiano
On Demand Access Anytime
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
By - Dr. Afsaneh Motamed Khorasani
On Demand Access Anytime
GAMP Data Integrity 21 CFR Part 11 Training Course
By - Kelly Thomas
On Demand Access Anytime
NEW Reclamation Process - Fed Gov't Payments
By - Donna K Olheiser
On Demand Access Anytime
Understanding and Preparing for FDA Pharmaceutical Inspections
By - Michael Ferrante
On Demand Access Anytime
How to conduct an effective BSA Audit
By - Justin Muscolino
On Demand Access Anytime
Installation and Qualification of the Packaging Lines
By - John E Lincoln
On Demand Access Anytime
Best Sellers
You Recently Viewed
    Loading