Pharmaceutical Impurity Control – Advanced Training

Description

Pharmaceutical Impurity Control – Advanced Training | QBD-Based | ICH Guidelines & Risk-Based Strategies

Upgrade your expertise with this QbD-Based Pharmaceutical Impurity Control Training, designed to help professionals move from traditional “testing-in quality” to a science- and risk-based approach where impurity control is built into the product and process design.

Aligned with ICH Q8, Q9, Q10, M7, and Q3 guidelines, this course provides a comprehensive understanding of impurity identification, control strategies, risk assessment, and regulatory compliance across the pharmaceutical lifecycle.

Course Overview

Fundamentals of QbD & Impurity Management

• Introduction to Quality by Design (QbD) principles
• Regulatory framework: ICH Q8 (Development), Q9 (Risk Management), Q10 (Pharmaceutical Quality System)
• Integration of impurity guidelines: ICH Q3A/B/C/D & M7
• Defining Quality Target Product Profile (QTPP) for impurity control

Impurity Control Modules

🔹 Chiral Impurities

• Identification, separation, and quantification strategies
• Use of HPLC, GC, and chiral techniques
• Regulatory expectations and best practices

Achiral (Process-Related) Impurities

• Monitoring synthetic and process-related impurities
• Impurity profiling and analytical method development
• Setting acceptable limits and documentation

Isomeric Impurities

• Understanding positional and stereoisomers
• Separation techniques using HPLC, LC-MS, and chiral columns
• Quantification and control strategies

Degradation Impurities

• Forced degradation studies: acid/base, thermal, oxidative, hydrolytic
• Photostability testing and light-induced degradation
• Development of stability-indicating methods

Genotoxic Impurities (ICH M7)

• Identification and control of mutagenic impurities
• Threshold of Toxicological Concern (TTC) and risk-based approaches
• Analytical and in-silico assessment tools

 Nitrosamine Impurities

• Regulatory concerns and global guidelines
• Screening, detection, and quantification
• Risk mitigation strategies in manufacturing

Elemental Impurities (ICH Q3D)

• Sources and risk evaluation
• Detection using ICP-MS, ICP-OES
• Limit setting and regulatory compliance

Impurity Control Strategy

• Determining where, how, and at what levels impurities should be controlled
• Use of risk assessment tools (TTC, in-silico models, SAS)
• Purge factor studies for process safety and compliance
• Integration with QbD and lifecycle management

Regulatory Guidelines

• ICH: Q3A, Q3B, Q3C, Q3D, M7, Q8, Q9, Q10
• Global expectations: USFDA, EMA
• Documentation, reporting, and submission readiness

Practical Learning & Case Studies

• 50+ real-world case studies across impurity types
• Analytical method development insights
• Troubleshooting strategies and regulatory tips
• Interview FAQs and expert guidance

Key Learning Outcomes

• Apply QbD principles to impurity control and process design
• Develop robust, compliant impurity control strategies
• Use risk management tools to prioritize and mitigate risks
• Optimize analytical methods using DoE (Design of Experiments)
• Ensure global regulatory compliance with confidence

Who Should Attend?

• Analytical scientists and AR&D professionals
• QA/QC and regulatory affairs professionals
• Pharma R&D and manufacturing teams
• Professionals working on impurity profiling and control

Why Choose This Course?

• Industry-focused, practical approach
• Aligned with global regulatory expectations
• Real-world case studies and hands-on insights
• Career-oriented, job-ready skills

Build expertise in modern impurity control strategies using QbD principles and stay ahead in the evolving pharmaceutical regulatory landscape.

Note: This training program is offered in flexible formats, including classroom (in-person), online courses (Foundation, Most Popular, and Advanced levels), as well as customised corporate training solutions for organisations.