Press Room

Webinar - Practical Management of Pharmaceutical Impurities

Wednesday, July 15, 2020 - 16:00
Wednesday, July 15, 2020 - 17:00
Location: online
Drug Substance pharmaceutical industry | Hovione

Wednesday, July 15th, 2020  |  11 am (EDT) / 4 pm (BST) / 5 pm (CEST)


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Marco Galésio - Analytical Chemist
Daniel Pereira - Analytical Chemist


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

  1. General pharmaceutical impurities management and control
  2. Control of Residual Solvent, ICH Q3C
  3. Control of Elemental Impurities, ICH Q3D
  4. Control of Genotoxic Impurities, ICH M7

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at  


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