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Pharmaceutical Drug Product Impurities

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Course Overview

 

Drug product impurities attract scrutiny during regulatory review and inspection because of their potential impact on patient safety. It is crucial for pharmaceutical professionals to understand the regulations and how to implement strategies to minimise impurities in drug products.

 

This training course examines the different types of chemical impurity of concern to regulators in chemical drug products.  In addition to ordinary organic degradation products, you will examine mutagenic impurities (including nitrosamines), residual solvents, elemental impurities and extractables/leachables. Once completed you will have the confidence to navigate the EU, US, USP and ICH regulations surrounding drug impurities.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • Learn about the regulatory background and recommendations for the control of impurities in drug products
  • Appreciate the different types of impurities and when/how to control them
  • Understand current and future industry trends, including the forthcoming ICH guidance on extractables and leachables (ICH Q3E)
  • Learn how to apply the principles of quality risk management to the control of different impurity types
  • Understand the importance of vendor documentation and how to use it
  • Be able to justify and document decisions regarding impurity control strategies
  • Be able to define and demonstrate FDA, EU, USP and ICH compliance to regulatory agencies
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Overview of regulatory guidance

  • Control of ordinary and mutagenic organic impurities (ICH Q and M guidance’s)
  • Distinction between synthetic impurities and degradation products
  • Safety of impurities (ICH S guidance’s)
  • Residual solvents and elemental impurities
  • Extractables and leachables

 

Case study: nitrosamines in valsartan tablets manufactured by Zhejiang Huahai Pharmaceuticals

 

Identifying new drug degradation products

  • Early information: retention time and UV spectrum
  • LC-MS: ionisation and mass analyser types vs. information quality
  • NMR
  • IR
  • Concentration by fraction collection or selective extraction
  • Confirmation of identity/toxicity by synthesis
  • Drug product stress studies to confirm mechanism of formation

 

Chirality and toxicity

 

Day 2

Qualifying/justifying limits for new degradation products

 

Genotoxic impurities – structural alerts and tests for genotoxicity

 

Toxicology testing in animals – rationale and types of test

 

Routes of administration and toxicity

 

Risk assessments

  • New degradation products
  • Nitrosamines
  • Elemental impurities
  • Residual solvents

 

Worked example: elemental impurities risk assessment

 

Dr. Mark Powell

is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff in technical writing.

 

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.

 

Mark not only brings a huge amount of knowledge and experience to his workshops but excellent at delivering interactive and engaging courses with multiple examples throughout.

This course is aimed at anyone involved in the control, monitoring and reporting of pharmaceutical drug product impurities. These includes: QA Managers and Personnel | Quality Control Scientists | Method Development Scientists | Analytical Chemists |Laboratory Personnel | Regulatory Affairs Professionals | Qualified Persons.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.
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