WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 4): Analytical Method Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 4): Analytical Method Validation
(2006; 27 pages)

Table des matières

Validation

General (2)

Tests include:

- identification tests

- assay of drug substances and pharmaceutical products

- content of impurities and limit tests for impurities

- dissolution testing and determination of particle size
Results should be reliable, accurate and reproducible

2.4 The most common analytical procedures include identification tests, assay of drug substances and pharmaceutical products, quantitative tests for content of impurities and limit tests for impurities. Other analytical procedures include dissolution testing and determination of particle size.

2.5 The results of analytical procedures should be reliable, accurate and reproducible. The characteristics that should be considered during validation of analytical methods are discussed in paragraph 6.