Forced degradation, by definition, means subjecting drugs and/or their packaged products to harsher conditions of catalytic external and internal factors, such as heat, moisture, pH, oxidants, metal species, light, etc. These studies help in development of stability-indicating methods that can detect the loss of the active component and rise in degradation products.
Forced degradation requirements have been briefly described in various international guidelines. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published a set of guidelines, that were discussed, agreed upon and adopted by the US, European and Japanese regulatory authorities. The ICH guidelines that mention of forced degradation requirements are:
• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• ICH Q1B – Photostability Testing of New Drug Substances and Products
• ICH Q2B – Validation of Analytical Procedures: Methodology
This specially designed masterclass is intended to provide a holistic understanding of the forced degradation requirements, benefits and advancements. Further, the widely applicable industry practices and handling of regulatory deficiencies will also be covered. The agenda features multiple Q/A sessions to ensure that the participants are amply able to interact with the Experts and get all their queries resolved.
This masterclass will be conducted physically on October 14, 2022, in Sheraton Hyderabad Hotel, Gachibowli, Hyderabad from 9.00 am to 5.00 pm with tea and lunch breaks provided as per the agenda.
Who Should Attend
Industry professionals from Analytical R&D, Quality Assurance and Regulatory departments working in API and Formulation manufacturing companies.
What Will I Get
1. Complete understanding about importance and scientific aspects of forced degradation
2. Protocol for characterization of degradation products using sophisticated hyphenated techniques
3. Quantitation and mass balance during forced degradation
4. Industry practices and handling of queries/deficiencies related to stress testing and suggested solutions
- Regulatory perspectives, benefits and advancements
- Quantitation of degradation products
- Characterization of degradation products
- Forced degradation practices in industry