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Analytical Method Validation - Lab Services - QbD Group

Method Validation

Ensuring reliable and compliant analytical procedures

Method validation is an essential process to confirm that analytical procedures meet regulatory requirements and deliver accurate, reproducible results.

At QbD Group, we ensure your methods align with global standards, such as ICH Q2(R1) and compendial guidelines, while tailoring them to your specific needs. Our expertise and robust validation processes provide confidence in the reliability and compliance of your analytical methods.

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What is method validation?

Method validation is a systematic process of evaluating analytical methods to ensure they consistently deliver reliable and accurate results for their intended purpose. This process verifies that methods meet predefined criteria and are suitable for regulatory submission and routine use. Key aspects of method validation include:

  • Regulatory Alignment: Following ICH Q2(R1), compendial, and client-specific guidelines.

  • Parameter Assessment: Evaluating accuracy, precision, specificity, linearity, and robustness.

  • Documentation: Comprehensive reporting of validation studies for regulatory compliance.

  • Transferability: Ensuring methods are ready for seamless transfer to contract providers if needed.

Discover why method validation is essential
Method Validation - Lab Services - QbD Group (1)

Why is method validation important?

Method validation is crucial for:

 

  • Regulatory approval: Ensures compliance with international standards and facilitates market access.
  • Product integrity: Confirms the quality, safety, and efficacy of pharmaceutical products.
  • Operational efficiency: Reduces risks of non-compliance and enhances analytical reliability.
  • Risk mitigation: Identifies and addresses potential weaknesses in analytical methods.
  • Routine testing readiness: Prepares methods for consistent application in quality control.
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How can we help?

At QbD Group, we offer comprehensive method validation services:

Regulatory expertise

Regulatory expertise

Adhering to ICH Q2(R1) and relevant guidelines.

Comprehensive validation

Comprehensive validation

Assessing all critical parameters, including accuracy, precision, and robustness.

Tailored protocols

Tailored protocols

Developing and executing validation protocols specific to your needs.

Validation reports

Validation reports

Providing detailed documentation for regulatory submission.

Transfer readiness

Transfer readiness

Preparing validated methods for transfer to external laboratories, if required.

Analytical Method Validation - Lab Services - QbD Group (1)

Why partner with QbD Group?

Partnering with QbD Group for method validation provides:

  • Regulatory knowledge: Extensive experience with global regulatory requirements.

  • Accurate results: Thorough validation processes to ensure method reliability.

  • Custom solutions: Tailored protocols to meet your project’s unique needs.

  • End-to-end support: Comprehensive assistance from validation planning to reporting.

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Ready to validate your analytical methods?

Ensure your analytical methods are reliable, compliant, and ready for routine use with QbD Group’s method validation services. Contact us today to discuss your project and learn how we can support your validation needs.

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