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Identification Testing and Discrimination of Related Structures

What This Course Is About

SLIDE 2 — Concept Simplified

Slide-by-Slide Content

SLIDE 3 — Case Study with Characters and Dialogue

SLIDE 4 — Practical Application

10-Point Audit Checklist — Identification Testing & Discrimination of Related Structures

Quiz

Risk Indicators to Watch For

Preventive Actions

AVOID

Part A — Quiz (5 Questions)

Survey and Feedback

Part B — Reflection

Quality Review Confirmation

Welcome to the comprehensive course on 'ICH Q2(R2) Identification Testing and Discrimination of Related Structures. ' In the highly regulated pharmaceutical industry, ensuring the exact identity of active pharmaceutical ingredients (APIs) and finished products is paramount for patient safety and regulatory compliance.

Welcome to the comprehensive course on 'ICH Q2(R2) Identification Testing and Discrimination of Related Structures.' In the highly regulated pharmaceutical industry, ensuring the exact identity of active pharmaceutical ingredients (APIs) and finished products is paramount for patient safety and regulatory compliance. This course dives deep into the fundamental concepts of identification testing and its specific regulatory purpose under ICH Q2(R2) Section 3.1.1. You will learn why the mere absence of analytical interference is insufficient proof of identity, and how to implement scientifically sound identification tests utilizing positive controls, negative controls, and structurally related challenge materials.

Through engaging, real-world case studies—including time-pressured batch release decisions and borderline compliance scenarios—you will develop the critical thinking skills necessary to make risk-based, science-driven decisions. We will guide you through a practical, step-by-step workflow for selecting and scientifically justifying related structures to challenge your ID methods against, helping you transition from generic checklists to documented scientific judgment. 

Finally, you will master a robust 10-Point Audit Checklist to evaluate identification testing protocols, detect critical omissions, and critique analytical method validation reports. Whether you are in Quality Assurance, Quality Control, or Regulatory Affairs, this course will empower you to formulate defensible specificity rationales that confidently withstand rigorous regulatory scrutiny and on-site inspections.

ICH Q2(R2) Identification Testing and Discrimination of Related Structures

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            <p>Ensuring the absolute identity of pharmaceutical materials is a foundational pillar of patient safety, product quality, and regulatory compliance. Under the ICH Q2(R2) guideline, specifically Section 3.1.1, identification testing requires far more than merely confirming the presence of an active ingredient; it demands the rigorous discrimination of closely related molecular structures. This course provides a comprehensive examination of the scientific and regulatory principles necessary to establish and defend robust identification methods. By exploring the critical necessity of positive controls, negative controls, and structurally related challenge materials, professionals across Quality Assurance, Quality Control, and Analytical Development will gain the expertise required to prevent product mix-ups and fortify the overarching control strategy.</p>

<p>Throughout this curriculum, participants will navigate the complexities of method specificity through practical, real-world case studies, including time-pressured batch release scenarios and borderline compliance decisions. The material systematically transitions from foundational theory to practical application, detailing step-by-step workflows for selecting and scientifically documenting challenge substances rather than relying on generic checklists. Furthermore, a specialized 10-point audit checklist will equip regulatory affairs staff and QA reviewers with the analytical tools to evaluate validation packages, detect critical omissions, and formulate defensible specificity rationales capable of withstanding stringent regulatory inspections. Whether designing a challenge panel in the laboratory, defending a dossier, or relying on identification test results for critical material disposition decisions, stakeholders will acquire actionable insights to ensure strict adherence to global regulatory expectations.</p>
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