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

Below is a more professional, industry-focused, and training-friendly version of your course while retaining the same technical content and flow.

Day 1 – Session 1

Fundamentals of Pharmaceutical Impurities

• Introduction to Pharmaceutical Impurities
• Definition and Regulatory Perspective
• Pharmaceutical Impurity Control Strategies
• Need for Effective Impurity Control
• Sources of Impurities in Drug Substances and Drug Products
• ICH Classification of Impurities
• Industry Case Studies

Day 2 – Session 2

Regulatory Guidelines and Impurity Terminology

• Global Regulatory Guidelines on Pharmaceutical Impurities
• Key Terminology and Concepts Related to Impurity Control
• Carryover Studies: Principles, Regulatory Expectations, and Case Studies

Day 3 – Session 3

Mechanisms of Impurity Formation

• Hydrolysis-Induced Impurities
• Decarboxylation Reactions
• Water Elimination (Dehydration) Pathways
• Racemization and Stereochemical Changes
• Tautomerization Processes
• Photocleavage Reactions
• Oxidative Degradation Mechanisms
• Practical Examples and Case Studies

Day 4 – Session 4

Identification, Isolation, and Characterization of Impurities

• Scientific Approaches for Unknown Impurity Identification
• Analytical Techniques for Impurity Investigation
• Isolation Strategies for Known and Unknown Impurities
• Structural Characterization and Confirmation
• Regulatory Expectations and Case Studies

Day 5 – Session 5

Scientific Strategies for Impurity Control

• Risk-Based Approaches to Impurity Control
• Scientific Justification Using Impurity Chemistry
• Quality by Design (QbD) for Impurity Management
• Purge Factor Calculation and Application
• Process Purification Strategies
• Process Monitoring and Impurity Tracking
• API Specification-Based Impurity Control
• Regulatory Interactions and Development Considerations

Day 6 – Session 6

Establishing Effective Impurity Control Points

• Determining Where, How, and at What Level Impurities Should Be Controlled
• Control of Starting Materials (SM) and Key Starting Materials (KSM)
• Management of Related Impurities in Raw Materials
• Supplier Qualification and Control of Purchased Materials
• Risk Assessment Approaches for Incoming Materials

Day 7 – Session 7

Process-Related Impurity Control

• Classification of Process-Related Impurities
• Process Development Strategies for Impurity Reduction
• Monitoring and Control During Manufacturing
• Investigation and Trending of Process Impurities
• Industry Case Studies

Day 8 – Session 8

Control of Isomeric Impurities

• Chiral Impurities and Enantiomeric Control
• Rotamers and Conformational Isomers
• Tautomeric Impurities
• Structural Isomers:
  • Positional Isomers
  • Geometrical Isomers
• Analytical and Regulatory Considerations

Day 9 – Session 9

Residual Solvents and Elemental Impurities

• Control of Residual Solvents (OVI)
• ICH Q3C Requirements and Risk Assessment
• Introduction to Elemental Impurities
• ICH Q3D Classification and Regulatory Expectations
• Risk-Based Control Strategies

Day 10 – Session 10

Control of Inorganic and Material-Derived Impurities

• Sources and Control of Inorganic Impurities
• Extractables and Leachables Assessment
• Polymorphic Impurities and Solid-State Control Strategies
• Regulatory Expectations and Case Examples

Day 11 – Session 11

Advanced Control of Degradation and Genotoxic Impurities

• Types and Sources of Degradation Products
• Control Strategies for Degradation Impurities
• Potential, Reasonably Expected, and Likely-to-Arise Impurities
• Control of DNA-Reactive (Mutagenic) Impurities
• Nitrosamine Risk Assessment and Control
• Genotoxicity Statements for APIs
• Threshold of Toxicological Concern (TTC) Concept
• Cohort of Concern and Regulatory Expectations
• Industry Case Studies

Day 12 – Session 12

Regulatory Compliance and Impurity Specification Design

• Common Regulatory Deficiency Letters Related to Impurity Control
• Benefits of Robust Impurity Control Strategies
• Design and Justification of Impurity Specifications
• Skip-Testing Approaches and Risk-Based Implementation
• Calculation and Evaluation of Total Number of Impurities in APIs
• Inspection Readiness and Best Practices

Key Learning Outcomes & Case Studies

Upon completion of this program, participants will be able to:

• Understand the origin, classification, and regulatory requirements of pharmaceutical impurities.
• Design scientifically justified impurity control strategies throughout the product lifecycle.
• Identify, isolate, and characterize known and unknown impurities.
• Apply QbD principles and risk-based approaches for impurity management.
• Control process-related, degradation, genotoxic, nitrosamine, elemental, residual solvent, and isomeric impurities.
• Develop compliant impurity specifications aligned with global regulatory expectations.
• Address regulatory queries and inspection observations related to impurity control effectively.
• 15+ real-world case studies across impurity types
• Interview FAQs and expert guidance

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.

Sessions: 12 sessions (18hours / 1080 minutes)

Target Audience: Analytical / QC / QA / RA / R&D

Mode of Training: Online (via Google Meet)

Certificate: Yes, a certificate of completion will be provided

Money-Back Guarantee: 30-day money-back guarantee

Language: English

Instructor: Dr Pramod Kumar Pandey (PhD in Chemistry) | 31+ years of experience in global and Indian pharmaceutical industries

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.