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Manufacture Standards & Regulation

Practical Management of Pharmaceutical Impurities

sponsored by Hovione

Available On-Demand

July 15, 2020,
11am EDT / 4pm BST / 5pm CEST

The management and control of pharmaceutical impurities is a matter of great concern and is an important part of drug development and regulatory assessment. Current regulations and guidelines demand a comprehensive understanding of the impurity profile of pharmaceutical products, as their safety and quality can be impacted by the presence of impurities. The nature and the quantity of impurities is affected by different factors, including synthetic route of the drug substance, quality of the starting raw materials, reagents, solvents, excipients, packaging and storage of the final product.

The ICH quality guidelines ICH Q3A and Q3B address questions related to the regulation of impurities in the drug substance and drug product, whereas other ICH quality guidelines address specific types of impurities, such as residual solvents and genotoxic impurities.

With this webinar we pretend to look at the different sorts of impurities that may occur in pharmaceutical products and discuss current regulations, requirements and control strategies to be followed in order to comply with the current demands.

Learning Objectives:

  • General pharmaceutical impurities management and control
  • Control of Residual Solvent, ICH Q3C
  • Control of Elemental Impurities, ICH Q3D
  • Control of Genotoxic Impurities, ICH M7

Available On-Demand

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