Last month, the FDA published this document for drug and biological license applicants submitting analytical procedures and methods validation data to document the identity, strength, quality, purity, and potency of drug substances and 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.
Computer and software related recommendations include:
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.
Download the FDA guidance here: Analytical Procedures and Methods Validation for Drugs and Biologics
Not sure what to make of this new guidance? Talk to our CSV experts about how it may affect your validation processes.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.