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

Cleaning validation protocols (5)

Bracketing:

Very similar cleaning procedures for products and processes - no need for individual validation. “Worst case” may be acceptable and should be justified.
Consider type of products and equipment; allowed only where products are similar in nature or property and processed on the same equipment; and identical cleaning procedures used.

4.1.4 Cleaning procedures for products and processes which are very similar do not need to be individually validated. A validation study of the “worst case” may be considered acceptable. There should be a justified validation programme for this approach referred to as “bracketing”, addressing critical issues relating to the selected product, equipment or process.

4.1.5 Where “bracketing” of products is done, consideration should be given to type of products and equipment.

4.1.6 Bracketing by product should be done only when the products concerned are similar in nature or property and will be processed using the same equipment. Identical cleaning procedures should then be used for these products.