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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

How to fill out validation of analytical test
01
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.
03
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.
06
Step 6: Review and interpret the validation results. Determine whether the analytical test meets the required standards and can be considered validated.
07
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?
01
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.
06
- 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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