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SpeakerValidation in Pharmaceutical Analysis
ICH Q2 Revision, Lifecycle Concept, Precision, and Accuracy,
Live Online Training on 13 March 2024Dr Joachim ErmerErmer Quality Consulting, GermanySpecificity/Selectivity,
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How to fill out validation in pharmaceutical analysis
How to fill out validation in pharmaceutical analysis
01
Determine the purpose of the validation study.
02
Define the validation parameters, such as accuracy, precision, specificity, and robustness.
03
Prepare a validation protocol outlining the procedures and acceptance criteria.
04
Perform the validation experiments according to the protocol.
05
Analyze the data and compare the results against the acceptance criteria.
06
Document the validation study results in a comprehensive report.
Who needs validation in pharmaceutical analysis?
01
Pharmaceutical companies conducting quality control testing on drug products.
02
Research laboratories developing new analytical methods for drug analysis.
03
Regulatory agencies overseeing the approval and monitoring of pharmaceutical products.
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What is validation in pharmaceutical analysis?
Validation in pharmaceutical analysis is the process of demonstrating and documenting that a method, process, or system is reliable, accurate, and reproducible.
Who is required to file validation in pharmaceutical analysis?
Pharmaceutical companies and laboratories are required to file validation in pharmaceutical analysis.
How to fill out validation in pharmaceutical analysis?
Validation in pharmaceutical analysis is filled out by following guidelines set by regulatory bodies and documenting all relevant data.
What is the purpose of validation in pharmaceutical analysis?
The purpose of validation in pharmaceutical analysis is to ensure the quality, safety, and efficacy of pharmaceutical products.
What information must be reported on validation in pharmaceutical analysis?
Information reported on validation in pharmaceutical analysis includes method validation data, system suitability data, and documentation of results.
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