Current developments for organic impurities in small molecule APIs and respective medicinal products

Impurities in small molecule active ingredients, excipients, medicinal products and packaging materials are important attributes in the assessment of quality and safety of medicinal products - this applies to all phases of the product life cycle. Not least the contamination by nitrosamines has changed regulators view of the subject and today we have to deal with the subject more intensively. Impurities are "on the move", applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds. This applies to projects with new products, but also to specific occasions, such as the renewal of marketing authorisations, the sourcing of new active substances and excipients, changes in production and site transfers.

Who should attend?

The course will provide an update on the current state of the art for the control of impurities in medicinal products with small molecules as API. It will provide a best practice guide how to control impurities and to avoid them by using appropriate approaches.There will be room for questions of the participants:

• People in charge for development of synthesis and control strategy for small molecule APIs
• People in charge for pharmaceutical development and control of medicinal products
• Regulatory Affairs Personnel
• Heads of quality control
• EU Qualified Persons

Module 1: Potential Impurities
Duration: about 90 minutes

In recent years, our view of how to deal with impurities in active pharmaceutical ingredients has changed fundamentally. On the one hand, it is of essential importance that today it is expected to anticipate already during pharmaceutical development, but also in case of changes in manufacturing or site transfers, which "potential impurities" could arise and whether they could get into the medicinal product and thus pose a risk to the patient. In order to answer this question, it is necessary to carry out a product-specific assessment and to establish the necessary experimental data. This context is presented in Module 1 of the training.

• Synthesis by-products and degradation products of API
  • Concept of related substances
  • What are potential impurities?
  • Impurity assessment
  • Control strategy for impurities

Module 2: Genotoxic impurities
Duration: about 85 minutes

The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products. While the ICH Guidelines Q3A and Q3B and the resulting EMA guidance documents provides guidance for qualification and control for impurities which result from synthesis, degradation and/or reaction with excipients, in these documents limited guidance is provided for those impurities that are DNA reactive. This topic is covered by the ICH M7 guideline which a harmonised practical framework that is applicable to the identification, categorisation, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk. All these aspects will be explained in the training.

• Obligations for applicants and marketing authorization holders as defined in ICH M7
• Risk assessment and toxicological aspects
• Structural analysis | Q(SAR) | In silico methods
• TTC approach
• Control strategy and strategic aspects for setting acceptance criteria

Module 3: Nitrosamines
Duration: about 80 minutes

The so-called "Valsartan scandal" has led to intensive discussions worldwide on the extent to which the measures and documentation obligations applied in the production of active substances and medicinal products are appropriate for the prevention of (genotoxic) contamination. In the training, important aspects in this context are presented and it is explained which expectations on the part of the authorities are to be expected in the future. This includes not only an appropriate risk assessment considering fate and purge of nitrosamines that can potentially be formed during synthesis or storage of active substances and medicinal products, but also an appropriate control strategy to avoid risks to patients.

• History and current developments in the field of potential nitrosamine impurities
• Risks for the formation of nitrosamines in chemical syntheses of active substances
• Other sources of nitrosamines in medicinal products known so far
• Risk assessments to be performed
• Control strategies
• Expectations by competent authorities in future and obligations of marketing authorization holders and applicants and manufactures

Key learning outcomes

• Detailed insights regarding the regulatory requirements in Europe
  • Related substances
  • Degradation products
  • Potential impurities
  • Genotoxic impurities
  • Nitrosamine Impurities
• Current developments related to the assessment for potential impurities in medicinal products
• Overview regarding different approaches for establishment of control strategies for impurities in APIs and medicinal products
• Awareness for risk assessments to be performed in the field of impurities

We offer attractive special prices with special benefits for large groups - please contact us.

Duration in total approx. 4,5 hours
Lecture language: English | Slides: English

The modules in this series can also be booked separately. You can find them in our course calendar.

You cannot attend the live event? No problem. Please inform us at the time of booking that you would like to stream the webinar at a later date.

Your speaker: Prof. Dr. Markus Veit is the managing director of ALPHATOPICS GmbH. He studied pharmacy in Frankfurt, obtained his doctorate at the Julius-Maximilians-University in Würzburg and was assistant professor there in the Department of Pharmaceutical Biology. He is a member of the German pharmacopeial expert committee at BfArM. In the past 25 years, he has worked as a managing director in companies providing services for the pharmaceutical industry with a focus on pharmaceutical development, testing and regulatory affairs. At the same time, he designed and led numerous training and continuing education events for employees in the pharmaceutical and medical device industry. He is an expert for herbal medicinal products and was involved in numerous applications for marketing authorisations of herbal medicines in Europe and rest of the world. In the past years he is increasingly involved in projects related to medicinal and other cannabis products.

Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Note on quota call-off: When booking the entire webinar series, three parts per trained person will be deducted.