WHO-GMP Validation for Pharmaceutical Mass Spectrometers

Data Integrity Regulations

Modern analytical laboratory instruments must meet strict validation procedures to survive US-FDA and WHO audits. The primary focus is data integrity: all data points must be attributed to an operator, generated concurrently, and backed by automated, non-editable audit trail files.

Validation Frameworks

This article outlines installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) frameworks for LC-MS/MS and GC-MS equipment.

Audit Readiness

Step-by-step checklist to pass laboratory data integrity checks according to 21 CFR Part 11 parameters.