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Validation of Analytical Test Procedures & Measurement UncertaintySPEAKERS:Dr Christopher Burgess Analytical Consultancy Limited, UK Trevor Comber Pharmaceutical Development Consultant, UDR Xavier
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How to fill out validation of analytical test

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Step 1: Start by reviewing the validation protocol provided with the analytical test. This protocol will outline the specific requirements and procedures for validation.
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Step 2: Prepare the necessary samples or materials for the analytical test. Follow the protocol's instructions on sample selection, preparation, and handling.
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Step 3: Perform the analytical test according to the protocol. Make sure to follow all the specified steps and record all relevant data.
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Step 4: Analyze the results obtained from the test. Compare them with the established acceptance criteria in the validation protocol.
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Step 5: Document the validation process, including all the steps taken, data collected, and results obtained. This documentation will serve as evidence of the test's validity.
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Step 6: Review and interpret the validation results. Determine whether the analytical test meets the required standards and can be considered validated.
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Step 7: Communicate the validation findings to the relevant stakeholders, such as laboratory supervisors, regulatory bodies, or clients, as necessary.
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Step 8: Periodically review and update the validation as needed, especially when changes occur in the analytical test's procedures, instruments, or personnel.
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Step 9: Follow any additional guidelines or regulations specific to the industry or field in which the analytical test is being used.

Who needs validation of analytical test?

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Validation of analytical tests is needed by various professionals and organizations, including:
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- Pharmaceutical companies to ensure the accuracy and reliability of drug analysis.
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- Clinical laboratories to validate diagnostic tests and ensure accurate patient results.
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- Environmental testing laboratories to verify the precision and effectiveness of pollution monitoring methods.
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- Food testing laboratories to validate the accuracy of nutritional and safety analyses.
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- Research institutions to validate new analytical techniques or methods.
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- Regulatory bodies to assess the validity of analytical tests used for product approvals or quality control.
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