Residual Solvents Reports
Risk assessments for residual solvents in pharmaceutical products
QbD Group specializes in risk assessments for residual solvents in human and veterinary drug products, helping identify risks, generate comprehensive reports, and address regulatory concerns per ICH Q3C guidelines.
What is residual solvent risk assessment?
Residual solvent risk assessment is a comprehensive evaluation of drug substances, excipients, and manufacturing processes aimed at identifying and mitigating risks associated with residual solvents. This process is designed to protect patients from potential adverse effects.
It includes three key steps:
- Analyzing potential residual solvents introduced during the manufacturing process.
- Evaluating actual or predicted solvent levels against established PDE values.
- Defining an effective control strategy based on the findings.
The importance of managing residual solvents
According to the ICH Q3C guideline, residual solvents offer no therapeutic benefit and can pose potential risks to patient safety.
Patient safety
Solvents must be removed to the greatest extent possible to protect patients.
Regulatory compliance
Meet product specifications, GMP, and other quality-based requirements.
Audit readiness
Updated, documented repository ensures preparedness for regulatory inspections.
Product quality
Maintain product integrity throughout the manufacturing process.
How we work: our process for residual solvent risk assessment
At QbD Group, we follow a structured approach to ensure a thorough and compliant residual solvent risk assessment.
1. Initial consultation
Understand your specific needs and regulatory concerns.
2. Data collection
Gather documentation regarding the drug product's manufacturing process.
3. Risk assessment report
Detailed report identifying potential sources of contamination per EMA guidelines.
4. Report delivery
Comprehensive report with solvent levels, PDE comparisons, and required controls.
5. Follow-up support
Ongoing support including acceptable limit calculations and detection limits.
Why QbD Group
Your trusted partner
Our EUROTOX-certified team ensures the highest standards of scientific quality in every residual solvent assessment.
End-to-end toxicology support
from early development to post-approval changes.
Trusted expertise at scale
decades of combined experience across diverse projects.
Proactive compliance monitoring
staying ahead of evolving solvent regulations.
Certified Toxicology Experts
EUROTOX-certified (ERT) toxicologists on every assessment.
Let's talk Toxicology
From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.