FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics, 07/15
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The US FDA published this document to provide recommendations on how drug and biological license applicants can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
This guidance is intended to complement the International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology for developing and validating analytical methods.
Here are some of the topics specific to computers and software:
- Section VII (Statistical Analysis and Models) Part A recommends the use of ‘appropriately validated software’ for statistical data analyses
- Section VII (Statistical Analysis and Models) Part B recommends the use of ‘suitable software’ for complex data modeling
- Section IV (Content of Analytical Procedures) Part H recommends System Suitability testing to ensure that equipment, electronics, and analytical methods function correctly as an integrated system
| Issuing Body | FDA Guidance Documents |
|---|---|
| Date Published | 2015 |
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