Dr Raphael Bar
BR Consulting
Referierende
Highlights:
• Overview of the basic chemistry of degradation reactions
• Overview of the basic chemistry of degradation reactions
• Practical aspects in designing and carrying out studies
• Performing stress studies to support the shipping and distribution of medicines
• Performing stress studies to support the shipping and distribution of medicines
Zielgruppe
Personnel from the following departments will benefit from this course:
- Stability personnel
- Analytical R&D
- Formulation development personnel
- Quality Control
- Quality Assurance (QA) and Regulatory Affairs (RA)
- Qualified Persons (QP)
Zielsetzung
This course aims to address the regulatory and practical aspects of designing and performing development studies under forced degradation conditions and under stress conditions.
Pharmaceutical companies perform forced degradation studies in order to:
- investigate potential degradation pathways;
- gain product knowledge;
- understand the intrinsic stability of the product;
- develop and confirm the stability-indicating nature of the analytical procedure.
The recent ICH Q1 draft (Stability Testing of Drug Substances and Drug Products) distinguishes between two categories of development studies undertaken to assess the effect of stress on the drug substance and/or drug product
- Studies conducted under stress conditions: Conditions are more severe than accelerated conditions but not necessarily intended to deliberately degrade the sample.
- Studies conducted under forced degradation conditions: Conditions are intended to deliberately degrade the sample (such as elevated temperature, humidity, pH, oxidation, agitation and light).
However, ICH Q1 as well as other guidelines do not provide practical, detailed laboratory guidance on how to perform any of the above development studies.
Programm
Day 1
Stress Testing, Forced Degradation and Regulations
- Regulations (ICH Q1A and draft ICH Q1, EU, US FDA and ANVISA)
- Chemical stress of drug substance and product
- Physical stress of excipients and active pharmaceutical ingredient (API)
- Purposes of forced degradation and product stress testing
Overview of Degradation Reactions of Pharmaceuticals
- Reactivity of common chemical functional groups
- Major mechanisms of chemical degradation
- Hydrolysis (acidic, alkaline)
- Oxidation (autoxidation, peroxide and metal-mediated)
- Interactions between API and excipients
Photodegradation of Pharmaceuticals According to ICH
- Basic terms in irradiation
- Essential terms of light irradiation
- Light chambers: Options 1 and 2 according to ICH
- Irradiation of drug substance and drug product samples
- Sequential versus simultaneous irradiation of UV and visible light
Design of Forced Degradation Studies
- Heat (with and without humidity)
- Acid and base
- Oxidation
- Is a forced degradation study a GMP study?
- Mechanical stress factors (e.g., grinding, milling, etc.)
Day 2
How to Perform Your Own Forced Degradation Study
- Heat and humidity
- Acid and base
- Oxidation
- Photolysis by UV and visible light
- Mechanical stress factors (e.g. grinding, milling …)
Ensuring that all Degradation Products are Detected
- Ensuring chromatographic elution of all degradation products (gradient mode, varying mobile phase solvents, various chromatography modes)
- Detecting all degradation products (LC-PDA, LC-MS, universal detector)
- Techniques to confirm the absence of undetected degradation products (flow injection analysis, UV spectrophotometric analysis)
- Determining peak purity by LC-PDA (spectral homogeneity and matching)
Mass Balance in Degraded Samples of Pharmaceuticals
- Definition and equations for mass balance
- Determination from chromatographic analysis of degraded samples
- Correction of mass balance for response factor
- Correction of mass balance for molecular weights
- Examples of mass balance calculations
Stress Testing to Support Shipping and Distribution of Pharmaceuticals and Biopharmaceuticals
- Studies at extreme high temperatures
- Studies at extreme low temperatures
- When, how and what?
- Thermal cycling studies (case study)
- Which attributes to test
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Fees
Non-ECA Members EUR 1,390
ECA Members EUR 1,190
APIC Members EUR 1,290
EU GMP Inspectorates EUR 695 per delegate plus VAT
The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Contacts
Questions regarding content:
Dr Markus Funk +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Maximilian Bauer +49 6221 84 44-25, bauer@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 4 May 2027, 09:00-13:15 h
Wed, 5 May 2027, 09:00-13:15 h
All times mentioned are CEST.
Wed, 5 May 2027, 09:00-13:15 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1190,- |
| Regular Fee*: | € 1390,- |
| EU/GMP Inspectorates*: | € 695,- |
| APIC Member Discount*: | € 1290,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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