WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation
(2006; 43 pages)

Table of Contents

Validation

Establishing acceptable limits (5)

The three most commonly used criteria are:

- Visually clean No residue visible on equipment after cleaning. Spiking studies to determine the concentration at which most active ingredients are visible. (May not be suitable for high potency, low-dosage drugs.)

- No more than 10 ppm of one product will appear in another product (basis for heavy metals in starting materials).

- No more than 0.1% of the normal therapeutic dose of one product will appear in the maximum daily dose of a subsequent product.

11.9 The three most commonly used criteria are:

visually clean. (No residue should be visible on equipment after cleaning.)

Spiking studies should determine the concentration at which most active ingredients are visible. This criterion may not be suitable for highpotency, low-dosage drugs;

no more than 10 ppm of one product will appear in another product (basis for heavy metals in starting materials); and
no more than 0.1% of the normal therapeutic dose of one product will appear in the maximum daily dose of a subsequent product.