Forced Degradation and Stress Studies - Live Online Training
From Regulatory Requirements to Practical Execution
4/5 May 2027
Course No. 23298
Speakers
Dr Raphael Bar
BR Consulting
Highlights: • 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
Target Group
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)
Objectives
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.
Programme
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
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
Further Information
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.
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.
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.
Testimonials
