Impurity Profiling of Drug substances and Drug products

The discussion will explore the control of organic, degradants, and genotoxic impurities in drug substances and products, emphasizing the importance of systematic approaches in identifying potential impurities and defining specifications for APIs and drug products, thereby ensuring quality control.
  • Tuesday
  • October
  • 22
  • 2024
08:00 AM PDT | 11:00 AM EDT
Duration: 90 Minutes
IMG Dr. Ganesh Prasad
Webinar Id: 60248
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview

Control of impurities in drug substances and drug products is very critical in assuring their quality. Types of impurities in finished product on its manufacturing process more so for drug substances. Systematic approach to identify potential impurities and define specifications of APIs which are generally made by multistep synthetic processes and also to define impurity specifications of drug products. The discussion will cover organic impurities, degradants and genotoxic impurities. Strategies to fix limits for these impurities will be discussed. 

Why you should Attend

Control of impurities during the manufacture of drug substances and drug products is very critical and hence a knowledge of strategies for identifying potential impurities and fixing appropriate limits is very essential.  

Areas Covered in the Session

  • Nature of impurities 
  • Potential impurities
  • Impurity characterization
  • Degradants 
  • Genotoxic impurities
  • Unspecified and Unknown impurities 
  • Fixing limits
  • Reporting impurities in COA

Who Will Benefit

  • QC Analysts
  • QA chemists and R&D and analytical R&D chemists
  • Personnel from Tech transfer

Speaker Profile

Dr. Ganesh Prasad is a freelance Pharma consultant in India under the banner ‘Q_Pharma consulting India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bengaluru. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, India and other organisations heading QA/QC/Process functions. He has also worked as scientist in the US FDA laboratory in Washington and other reputed institutions in USA/ Canada/India. He has together more than 30 years of experience together in quality assurance function, research in academia and industry. As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards of US FDA, European and Indian regulatory agencies. He also conducts third party quality audits of pharmaceutical manufacturers. He has conducted many public and in-house workshops and delivered invited lectures in forums like UBM, ISPE, DIA and so on.