Pharmaceutical Analytical Methods Validation, Verification and Transfer

Why Pharmaceutical Analytical Methods Validation, Verification, and Transfer are Needed?

Analytical methods validation, verification, and transfer are critical steps in ensuring the accuracy, reliability, and reproducibility of analytical test methods used for quality control and regulatory compliance in various industries such as pharmaceuticals, food and beverage, environmental testing, and clinical diagnostics. Especially for drug development, analytical methods validation, verification, and transfer are important in selecting and optimizing methods for testing raw materials, intermediate materials, final containers, and excipients, and ensuring data compliance with current good manufacturing practices (cGMP). As a necessary testing method, this strategy can ensure the quality, safety, and effectiveness of the product and comply with regulatory requirements.

Pharmaceutical Analytical Methods Validation and Verification Services

CD Formulation develops standardized verification procedures for your small molecules, large molecules, new drugs, generic drugs and innovative drug delivery systems in accordance with industry standards and regulatory guidelines. We generally provide the following three types of verification services:

• Comprehensive validation: involves newly developed methods.
• Partial validation: involves modifying a validated method.
• Cross-validation: involves comparing validation parameters when using multiple methods.

Our list of available services includes but is not limited to:

• Verify accuracy and precision to ensure consistency between measured values and true values.
• Establish linearity and range to ensure reliable quantification of different analyte concentrations.
• Determine the limit of detection (LOD) and limit of quantification (LOQ) to assess method sensitivity.
• Establish system suitability criteria to ensure proper operation of analytical instruments.
• Test specificity and selectivity to accurately measure the analyte of interest.
• Assess the robustness and durability to identify potential sources of variation for biological products.

Our Analytical Standards for Pharmaceutical Analytical Methods Validation and Verification:

• Precision
• Accuracy
• Reproducibility
• Repeatability
• Specificity and selectivity
• Linearity
• Scope
• Limit of detection (LOD)
• Limit of quantification (LOQ)
• Stability
• Robustness/ruggedness
• Suitability
• Forced degradation

Analytical Methods Transfer Services

Formal transfer of analytical methods is an essential cGMP process for drug development. This process is designed to ensure that established analytical procedures perform as expected in the receiving laboratory. CD Formulation provides cGMP-based analytical method transfer services and adheres to internationally recognized quality management standards to ensure the correctness and reliability of analytical methods.

Our list of available services includes but is not limited to:

• Develop a comprehensive transfer protocol involving outlining key steps and acceptance criteria.
• Conduct comparative testing to confirm the equivalence of transfer methods.
• Conduct co-validation and intermediate precision studies to obtain data for assessing reproducibility.
• Re-validation/partial re-validation is performed to ensure the accuracy and completeness of the information when comparative testing is not available at the transfer laboratory.
• Optimize methods as needed to ensure suitability and compliance.

Importantly, not only do we support the transfer of your methods and techniques to one or more external laboratories or our analytical laboratories for ongoing research, but we can also assess whether those methods we have developed and/or validated can be easily transferred to your required laboratory, making sure any limitations are included and considered.

Unique Advantages of Our Services

• Has extensive experience in performing analytical methods validation, verification, and transfer of various types of samples including sustained-release oral preparations, complex injections, transdermal patches, API, excipient, and finished products.
• We provide stage-appropriate method validation.
• All our work processes strictly comply with cGMP requirements.
• We provide fast turnaround time for method feasibility assessment, protocol execution, and final report generation.
• Our analytical laboratories offer flexible processes for more complex and/or technology-based methods.
• Typical analytical characteristics are used, including accuracy, precision, specificity, LOD/LOQ, linearity, range, and robustness.

CD Formulation has extensive expertise in analytical method development, validation, and transfer for the development as well as commercial product launch and stability testing in the field of innovative delivery systems. Whether you want to develop and validate new analytical methods or transfer analytical methods, we can provide professional technical support and services. Please contact us to learn more about our services and technical advantages!