Webinar: Impurities coming from Supply Chains

Webinar: Impurities coming from Supply Chains

Course No 18526

Important: Registration deadline is 12 noon on 11 January 2021.
All times mentioned are CET.


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Jürgen Martin, Martin Consulting, Germany


Pharmaceutical products are typically distributed within a network of global supply chains between API-, excipient- and packaging material suppliers and sites in pharmaceutical industry. It is one key part of GMP-activities to make sure impurities coming from the supply chain are managed adequately to avoid any product quality risk. Currently elemental impurities (covered by ICH Q3D Guideline) but also Nitrosamines (covered e.g. by EMA documents published in September 2019) are in the focus of the authorities. To manage these challenges risk management according to ICH Q9 guideline is a common and helpful tool to be in compliance for such topics in an efficient and ongoing way.

Target Group

The webinar addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.

Technical Requirements

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In this webinar you will get to know how the risks of contamination associated with supply chains can adequately be evaluated. The following aspects will be addressed:
  • Process mapping to understand impact factors to product quality
  • Risk measurement and evaluation of process steps according to ICHQ9
  • Vendor audits as important activity for processes knowledge and
  • to monitor the quality level
  • Vendor complaint tracking as important source for quality level
  • evaluation
  • Definition of adequate in-house testing programs for impurities
  • Risk based approach for supplier quality evaluation
  • Defining mitigation activities (e.g. adjusted sampling and testing approach)
  • Software support for information tracking
In order to illustrate the causal relations some case studies will be provided.

The duration of the webinar is 1.5 hours.

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