Lecture 27 Flashcards
What is validation/qualification?
Validation/qualification is the process of demonstrating that any procedure or system performs as intended, proving that it reliably accomplishes its designed purpose.
How is microbiology method validation achieved?
Through documents like the Validation Master Plan (VMP) and Method Validation Protocols (MVPs), using standard/reference methods, method development, and validating new test methods to ensure they are equal to or better than existing methods.
What tasks are involved in method validation?
Specificity: Proving the method can accurately detect the target microorganism.
Sensitivity: Demonstrating the method’s ability to detect microorganisms at required levels.
Limits of Sensitivity: Determining the method’s limit of detection (LOD) and quantification (LOQ).
Accuracy: Assessing the method’s accuracy through recovery studies.
Controls: Implementing positive and negative controls for reliability Volume Checks: Ensuring liquid volumes are accurate
What is involved in a comprehensive account of methods validation in microbiological analysis?
Defining the Scope: Specifying targeted microorganisms and the test’s purpose.
Selecting a Suitable Method: Choosing an appropriate method for the microorganism and purpose.
Developing Validation Protocols: Outlining all steps in the validation process.
Evaluating Method Performance: Conducting experiments to evaluate performance.
Documenting Results: Documenting results, observations, and calculations.
Establishing Acceptance Criteria: Defining clear criteria based on the test’s use and regulations.
Training and Qualification: Ensuring analysts are trained and competent.
What are positive and negative microbiological controls in method validation?
Positive Controls: Demonstrate the method can detect the target microorganism (e.g., growth promotion tests, spiked samples).
Negative Controls: Confirm the absence of contamination (e.g., sterility of media, uninoculated samples).
What validation tests are performed in a microbiology testing laboratory?
Specificity Testing: Confirms the method accurately distinguishes the target microorganism.
Sensitivity Testing: Determines the lowest detectable level of microorganisms.
Precision Testing: Assesses reproducibility of results.
Robustness Testing: Tests the method’s ability to withstand minor variations.
What control tests are performed in a microbiology testing laboratory?
ositive Controls: Verify detection of the target microorganism.
Negative Controls: Confirm the test system is contamination-free.
Media Sterility Checks: Ensure media used is sterile.
Equipment Sterility Checks: Verify equipment is sterile.
Environmental Monitoring: Monitors microbiological quality in the lab.
Analyst Proficiency Testing: Assesses analysts’ competency in performing tests.
