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Residual Solvents Reports

Are you looking to ensure compliance with regulations regarding residual solvents in pharmaceutical products?

At QbD Group, we specialize in risk assessments for residual solvents in both human and veterinary drug products. Our expert team helps you identify potential risks, generate comprehensive risk assessment reports, and address regulatory agency concerns. With a dedicated team of toxicology professionals, we can develop customized toxicology reports to meet your specific needs and regulatory requirements.

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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:

  1. Analyzing potential residual solvents introduced during the manufacturing process.
  2. Evaluating actual or predicted solvent levels and comparing them against established Permitted Daily Exposure (PDE) values.
  3. Defining an effective control strategy based on the findings.

By following these steps, we help ensure compliance with regulatory standards while prioritizing patient safety.

The importance of managing residual solvents in pharmaceuticals

Residual solvents in pharmaceuticals are organic volatile chemicals used or produced during the manufacture of drug substances, excipients, or products. According to the ICH Q3C guideline, these solvents offer no therapeutic benefit and can pose potential risks to patient safety. Therefore, it is crucial to remove them to the greatest extent possible to meet product specifications, Good Manufacturing Practices (GMPs), and other quality-based requirements.

By conducting a thorough residual solvent risk assessment, you ensure that your products meet regulatory standards, protect patient health, and maintain product quality throughout the manufacturing process.

 

 

What are the benefits?

An updated, documented repository of residual solvent risk assessments ensures that you are prepared for regulatory inspections and audits, providing the necessary documentation authorities may request.

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 for your pharmaceutical products. Here’s how we work:

Initial consultation
We begin by understanding your specific needs and regulatory concerns to tailor the process to your requirements.

Step 1

Data collection
We gather all necessary documentation regarding the drug product’s manufacturing process, including statements and questionnaires from component manufacturers.

Step 2

Risk assessment report
Our experts prepare a detailed residual solvent risk assessment report, identifying potential sources of contamination in line with current EMA guidelines.

Step 3

Report delivery
We provide a comprehensive report outlining the observed or predicted levels of residual solvents, their comparison to Permitted Daily Exposure (PDE) values, and any additional controls required.

Step 4

Follow-Up support
We offer ongoing support, including calculations of acceptable limits and detection limits for confirmatory testing, ensuring continued compliance.

Step 5

Why QbD Group?

  • End-to-end toxicology support
    From early development to post-approval changes, we provide integrated risk assessments seamlessly aligned with QA, CMC, and regulatory strategies.
  • Trusted expertise at scale
    With decades of combined experience across diverse projects and markets, our toxicology team provides reliable insights that add efficiency, consistency, and confidence to every assessment.
  • Proactive compliance monitoring
    Through strict oversight of reports, we help clients stay in full control of toxicology obligations, proactively alerting them to potential non-conformities before they become risks.
  • Certified Toxicology Experts 
    Our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety across every assessment.


    EUTOTOX
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End-to-end toxicology support

10+ years of experience

Compliance monitoring

Certified toxicology experts

 

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Reach out for expert guidance on residual solvent risk assessments.

Have questions or need more information? Fill out the form, and our team will be happy to help you with tailored solutions for your pharmaceutical products.

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