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Analytical Methods Qualification and Validation

Benefit from our efficient analytical methods qualification and validation by utilizing our knowledge and expertise, while providing relevant documentation supply for future product development and approval.

With you on your biologics journey...

Why implement analytical methods validation and qualification?

Analytical method qualification is the first documented measurement of the method’s performance under the relevant guidelines and its scientific purpose.

Validation, however, demonstrates the analytical procedure’s suitability for its intended purpose by following pre-defined objectives gathered from development and qualification activities. During the early stages of product development, qualification can be sufficient. However, validation of the analytical methods is necessary when closer to the registration of the product.

3P’s analytical methods qualification and validation services

We produce standard operating procedures (SOPs) with system suitability testing (SST) and assay acceptance criteria during our analytical methods qualification activities and produce a method qualification report detailing the findings and justifying the conclusions. Data from the qualification study will be used in developing the criteria for validation, which requires a more stringent approach.

Our approach to validation is to take pre-defined acceptance criteria for each method and follow relevant guidelines. We prepare the validation protocol, which is followed by documenting all data and the acceptance limit of the method in all parameters required (including specificity, linearity, range, accuracy, precision, quantification, detection limit) according to the particular assay. These activities are performed within 3P’s quality system and require formal protocol, report, and SOP updates.

What we will deliver

We provide efficient analytical methods qualification and validation by utilizing our knowledge and expertise to provide all relevant documentation and support, allowing for further product development and approval.

Our dedicated team of specialists will be happy to discuss any of your Analytical Methods Qualification And Validation needs. Contact us on +34 948 346 480 or email withinus@3pbio.com

Analytical Methods Validation

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