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1

Impurity Qualification as per ICHQ3A/ ICHQ3B

Impurity Qualification as per ICH Q3A (Impurities in New Drug Substances) and ICH Q3B (Impurities in New Drug Products) is a critical process in pharmaceutical development. It involves the identification, quantification, and toxicological evaluation of impurities in drug substances  and drug products to ensure their safety and quality.

2

Elemental Impurity Assessment as per ICHQ3D

Elemental Impurity Assessment as per ICH Q3D involves evaluating and controlling trace levels of elemental contaminants (heavy metals) in pharmaceutical products to ensure patient safety.

3

Impurity Assessment for Residual Solvent as per ICHQ3C 

ICH Q3C provides guidelines for the acceptable limits of residual solvents in pharmaceuticals to ensure product safety and quality.

4

Genotoxic Assessment of Impurities as per ICHM7

It is the evaluation of mutagenic impurities in pharmaceuticals to identify and control DNA- reactive substances that may cause genetic mutations or cancer.

7

Extractable and Leachables Toxicology Assessment as per ICH Q3E (under draft)​

Evaluation of potential chemicals that could leach from packaging into pharmaceutical products, ensuring product safety and regulatory compliance.

5

Nitrosamine Risk Assessment​

Potentially carcinogenic compounds may form inadvertently during drug production. Regulators worldwide demand stringent monitoring and control to limit them. Comprehensive risk assessments identify sources, evaluate exposure risks, and uphold both patient safety and regulatory standards.

6

Excipient Evaluation and Justification for the Proposed Limit​

Excipient evaluation involves assessing the safety, quality, and suitability of excipients used in pharmaceutical formulations. The justification for the proposed limit ensures that the excipient levels do not negatively impact the drug’s efficacy, stability, or patient safety.

Topic Walkthrough

What is impurity qualification?

Impurity qualification is the process of evaluating and establishing the safety of an impurity present in a drug substance (ICH Q3A) or drug product (ICH Q3B) at a specified level, ensuring it does not pose a risk to patients. ​ 

Why is impurity qualification important?

Impurity qualification is essential to:

  • Ensure patient safety by identifying toxic impurities.
  • Maintain drug quality and stability over time.
  • Meet regulatory requirements (FDA, EMA, ICH).
  • Reduce manufacturing risks and ensure process control.
  • Prevent regulatory rejection and product recalls.

What is Extractables & Leachables (E&L) Risk Assessment?

It is the evaluation of potential chemical compounds that may migrate from packaging materials into pharmaceutical products, ensuring safety and compliance.​ 

What is Genotoxicity Assessment?​

It is the evaluation of mutagenic impurities in pharmaceuticals to identify and control DNA- reactive substances that may cause genetic mutations or cancer.

What is Nitrosamine Risk Assessment?​

It is the process of identifying, evaluating, and controlling nitrosamine impurities in pharmaceutical products to ensure patient safety.